TriangleNCT00686959 · STUDY IN CONTEXT
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \[poss related\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.
Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.
Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- trial label
- Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0003
- source section id
- NCT00686959-om-0003
- source outcome index
- 3
- endpoint
- Adverse Events: The Number of Deaths Per Treatment Group
- endpoint definition
- The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related \[poss related\] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- time origin
- Baseline through 30 Days Post Study
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants who received at least one dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0000
- source section id
- NCT00686959-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.
- time origin
- Baseline to Date of Death from Any Cause (Up to 71.4 Months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0001
- source section id
- NCT00686959-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.
- time origin
- Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0002
- source section id
- NCT00686959-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (Complete Response [CR] + Partial Response [PR])
- endpoint definition
- Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
- time origin
- Baseline to Measured Progressive Disease (Up to 7 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0004
- source section id
- NCT00686959-om-0004
- source outcome index
- 4
- endpoint
- Survival Rates at 1, 2, and 3 Years
- endpoint definition
- The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
- time origin
- Baseline to Date of Death from Any Cause (Up to 71.4 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0005
- source section id
- NCT00686959-om-0005
- source outcome index
- 5
- endpoint
- First Site of Disease Failure in Terms of Relapse
- endpoint definition
- The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.
- time origin
- Baseline to Relapse (Up to 66.6 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants with objective PD.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A: Pemetrexed + Cisplatin and TRT
- regimen
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- analyzed count
- 301
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B: Etoposide + Cisplatin and TRT
- regimen
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- analyzed count
- 297
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A: Pemetrexed + Cisplatin and TRT
- regimen
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- analyzed count
- 301
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B: Etoposide + Cisplatin and TRT
- regimen
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- analyzed count
- 297
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A: Pemetrexed + Cisplatin and TRT
- regimen
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- analyzed count
- 301
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B: Etoposide + Cisplatin and TRT
- regimen
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- analyzed count
- 297
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A: Pemetrexed + Cisplatin and TRT
- regimen
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- analyzed count
- 283
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B: Etoposide + Cisplatin and TRT
- regimen
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- analyzed count
- 272
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm A: Pemetrexed + Cisplatin and TRT
- regimen
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- analyzed count
- 301
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm B: Etoposide + Cisplatin and TRT
- regimen
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- analyzed count
- 297
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm A: Pemetrexed + Cisplatin and TRT
- regimen
- Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
- analyzed count
- 166
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm B: Etoposide + Cisplatin and TRT
- regimen
- Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
- analyzed count
- 190
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00686959-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- harm key
- EG000
- source section id
- NCT00686959-ae
- event group key
- EG000
- event group label
- Arm A:
- serious affected
- 134
- serious at risk
- 283
- other affected
- 279
- other at risk
- 283
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Randomized participants who received at least one dose of study drug.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- nct id
- NCT00686959
- harm key
- EG001
- source section id
- NCT00686959-ae
- event group key
- EG001
- event group label
- Arm B: Etoposide + Cisplatin and TRT
- serious affected
- 145
- serious at risk
- 272
- other affected
- 269
- other at risk
- 272
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Randomized participants who received at least one dose of study drug.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice