Trial Outcomes & Findings for Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) (NCT NCT03739710)

Results Overview

Number of Participants randomized across sub studies are presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

175 participants

Primary outcome timeframe

Day 1

Results posted on

2025-06-15

Participant Flow

This master record includes data of screened participants for its sub-studies, 205801-001 (NCT05553808), 205801-002 (NCT06790303) and 205801-003 (NCT06926673) and only contains data during screening phase (Day -28 to Day 0). Results are presented separately for each sub study.

A total of 256 participants started the overall study which includes all who were screened prior to enrollment. However, 175 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	All Screened Participants Participants with Non-Small Cell Lung Cancer (NSCLC) were screened to be enrolled in sub-studies of this master protocol.
Overall Study STARTED	256
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Reasons for withdrawal
Measure	All Screened Participants Participants with Non-Small Cell Lung Cancer (NSCLC) were screened to be enrolled in sub-studies of this master protocol.
Overall Study Screen Failed	81

Baseline Characteristics

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Screened Participants n=256 Participants Participants with Non-Small Cell Lung Cancer (NSCLC) were screened to be enrolled in sub-studies of this master protocol.
Age, Customized 18-64 years	127 Participants n=5 Participants
Age, Customized Over 64 years	129 Participants n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants
Race/Ethnicity, Customized White	216 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	12 Participants n=5 Participants
Race/Ethnicity, Customized All other races	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Randomized Population included all participants who passed screening and were assigned treatment.

Number of Participants randomized across sub studies are presented.

Outcome measures

Outcome measures
Measure	All Screened Participants n=175 Participants Participants with Non-Small Cell Lung Cancer (NSCLC) were screened to be enrolled in sub-studies of this master protocol.
Number of Participants Randomized Across Sub-studies Sub Study 2	8 Participants
Number of Participants Randomized Across Sub-studies Sub Study 3	62 Participants
Number of Participants Randomized Across Sub-studies Sub Study 1	105 Participants

Adverse Events

All Screened Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER