RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

Draft scope assessment: unclear. Attached because the study's own record names EGFR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.

Source null

→

secondary · POSTED

Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.

Source null

→

secondary · POSTED

The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1), assessed up to 49 months.

Source null

→

secondary · POSTED

Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-iressa-7aece853
nct id: NCT02489903
trial label: RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
applicability: unclear
applicability note: Attached because the study's own record names EGFR. 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: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0000
source section id
NCT02489903-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.
time origin
From start of treatment through death for up to 64 months from Start of Treatment.
analysis role
primary
reporting status
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-iressa-7aece853
nct id
NCT02489903
outcome key
om-0001
source section id
NCT02489903-om-0001
source outcome index
1
endpoint
Overall Response Rate (ORR)
endpoint definition
Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.
time origin
Assessed up to 49 months
analysis role
secondary
reporting status
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-iressa-7aece853
nct id
NCT02489903
outcome key
om-0002
source section id
NCT02489903-om-0002
source outcome index
2
endpoint
Disease Control Rate (DCR)
endpoint definition
The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1), assessed up to 49 months.
time origin
Assessed up to 49 months
analysis role
secondary
reporting status
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-iressa-7aece853
nct id
NCT02489903
outcome key
om-0003
source section id
NCT02489903-om-0003
source outcome index
3
endpoint
Progression Free Survival (PFS)
endpoint definition
Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.
time origin
Assessed up to 49 months
analysis role
secondary
reporting status
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

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0000
arm key
OG000
arm label
RRx-001 + Platinum Doublet (A01-09)
regimen
4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
analyzed count
89
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0000
arm key
OG001
arm label
RRx-001 + Platinum + RRx-001 (A10)
regimen
RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0000
arm key
OG002
arm label
Investigator's Choice (A10)
regimen
Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0001
arm key
OG000
arm label
RRx-001 + Platinum Doublet (A01-09)
regimen
4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
analyzed count
89
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0001
arm key
OG001
arm label
RRx-001 + Platinum + RRx-001 (A10)
regimen
RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0001
arm key
OG002
arm label
Investigator's Choice (A10)
regimen
Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0002
arm key
OG000
arm label
RRx-001 + Platinum Doublet (A01-09)
regimen
4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
analyzed count
89
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0002
arm key
OG001
arm label
RRx-001 + Platinum + RRx-001 (A10)
regimen
RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0002
arm key
OG002
arm label
Investigator's Choice (A10)
regimen
Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0003
arm key
OG000
arm label
RRx-001 + Platinum Doublet (A01-09)
regimen
4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
analyzed count
89
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0003
arm key
OG001
arm label
RRx-001 + Platinum + RRx-001 (A10)
regimen
RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
outcome key
om-0003
arm key
OG002
arm label
Investigator's Choice (A10)
regimen
Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02489903-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02489903
harm key
EG000
source section id
NCT02489903-ae
event group key
EG000
event group label
RRx-001 + Platinum Doublet (A01-09)
serious affected
55
serious at risk
89
other affected
89
other at risk
89
frequency threshold
5
collection period
Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug.
event definition
All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
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-iressa-7aece853
nct id
NCT02489903
harm key
EG001
source section id
NCT02489903-ae
event group key
EG001
event group label
RRx-001 + Platinum + RRx-001 (A10)
serious affected
6
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug.
event definition
All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
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-iressa-7aece853
nct id
NCT02489903
harm key
EG002
source section id
NCT02489903-ae
event group key
EG002
event group label
Investigator's Choice (A10)
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
Adverse Events were collected beginning at baseline through end of treatment (28 days after last dose of study drug), up to 64 months. All-Cause Mortality was assessed from baseline through 28 days after last dose of study drug.
event definition
All Serious Adverse Events are reported irregardless of attribution. Adverse events are reported for related to study treamtent. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
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