TriangleNCT03456076 · STUDY IN CONTEXT
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Draft scope assessment: unclear. Attached because the study's own record names ALK. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Plasma Concentration of Alectinib
Plasma Concentration of Alectinib Metabolite M4
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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- trial label
- A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names ALK. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0000
- source section id
- NCT03456076-om-0000
- source outcome index
- 0
- endpoint
- Disease-free Survival (DFS), as Assessed by the Investigator
- endpoint definition
- DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
- time origin
- Approximately 58 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The ITT population consisted of all randomized participants, whether or not the participant received the assigned treatment. The Stage II-IIIa population consisted of all participants in the ITT population with Stage II-IIIa NSCLC.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0001
- source section id
- NCT03456076-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.
- time origin
- From the date of randomization until death due to any cause up to approximately 8 years
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0002
- source section id
- NCT03456076-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Adverse Events (AEs)
- endpoint definition
- An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
- time origin
- Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0003
- source section id
- NCT03456076-om-0003
- source outcome index
- 3
- endpoint
- AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms
- endpoint definition
- An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
- time origin
- Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety-evaluable population consisted of all participants who received at least one dose of study treatment, with participants assigned to treatment groups according to the treatment received. All participants who received any dose of alectinib are included in the alectinib treatment arm.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0004
- source section id
- NCT03456076-om-0004
- source outcome index
- 4
- endpoint
- Plasma Concentration of Alectinib
- endpoint definition
- Plasma Concentration of Alectinib
- time origin
- Predose (2 hours) Week 3 - Week 96
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0005
- source section id
- NCT03456076-om-0005
- source outcome index
- 5
- endpoint
- Plasma Concentration of Alectinib Metabolite M4
- endpoint definition
- Plasma Concentration of Alectinib Metabolite M4
- time origin
- Predose (2 hours) Week 3 - Week 96
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The PK-evaluable population consisted of all participants who received at least one dose of alectinib and who had at least one post-baseline PK sample available. This population did not include participants from the platinum-based chemotherapy arm, who did not receive alectinib.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Alectinib
- regimen
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Platinum-Based Chemotherapy
- regimen
- Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Alectinib
- regimen
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- analyzed count
- 128
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Platinum-Based Chemotherapy
- regimen
- Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
- analyzed count
- 120
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Alectinib
- regimen
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- analyzed count
- 128
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Platinum-Based Chemotherapy
- regimen
- Participants received platinum-based chemotherapy for 4 cycles (cycle length = 21 days).
- analyzed count
- 120
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Alectinib
- regimen
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- analyzed count
- 124
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Alectinib
- regimen
- Participants received 600 mg oral alectinib twice daily (BID) for 2 years
- analyzed count
- 124
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03456076-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer-ensacove-fb8dd0c5
- nct id
- NCT03456076
- harm key
- EG000
- source section id
- NCT03456076-ae
- event group key
- EG000
- event group label
- Alectinib
- serious affected
- 17
- serious at risk
- 128
- other affected
- 124
- other at risk
- 128
- frequency threshold
- 5
- collection period
- Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
- event definition
- All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
- 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-ensacove-fb8dd0c5
- nct id
- NCT03456076
- harm key
- EG001
- source section id
- NCT03456076-ae
- event group key
- EG001
- event group label
- Platinum-Based Chemotherapy
- serious affected
- 10
- serious at risk
- 120
- other affected
- 110
- other at risk
- 120
- frequency threshold
- 5
- collection period
- Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
- event definition
- All-cause mortality is reported for all participants. SAEs and Other AEs are reported for the safety-evaluable population, which consisted of all randomized participants who were enrolled during the global enrollment phase and received any amount of study drug, with participants grouped according to treatment received.
- 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