Trial · NCT02785939

Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer

NCT02785939, Phase 2, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2021-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer. Trials, record NCT02785939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02785939

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
NCT number: NCT02785939
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 53 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: CCND1 Gene Amplification, CCND2 Gene Amplification, CCND3 Gene Amplification, CDK4 Gene Amplification, Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Interventions: Docetaxel, Laboratory Biomarker Analysis, Palbociclib
First posted: 2016-05-30
Last updated: 2021-05-27
Results first posted: 2021-05-27

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial)	From date of registration to progression or treatment discontinuation, up to 2 years and 10 months.	The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with palbociclib per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment
Secondary	Duration of Response Among Participants Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1	From date of registration to maximum of 2 years and 10 months or death	From date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a complete or partial response. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment
Secondary	Overall Survival With Investigational Therapy	From date of registration to maximum of 2 years and 10 months or death	From date of sub-study registration until death due to any cause. It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment
Secondary	Progression-free Survival With Palbociclib.	From date of registration to maximum of 2 years and 10 months or death	From date of sub-study registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment
Secondary	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death	Adverse Events (AEs) are reported per CTCAE Version 5.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment
Other	Screen Success Rate, Monitored by the Percentage of Screened Patients That Register to a Therapeutic Sub-study	Up to 3 years	Screen success rate is defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy.
Other	Treatment Arm Randomization Acceptance Rate, Monitored by the Percentage of Patients That Receive at Least One Dose of the Treatment They Are Randomized to	Up to 3 years	Treatment arm randomization acceptance rate within each treatment arm of each randomized sub-study is defined as the ratio of the number of patients who receive any protocol treatment over the number that are randomized to that sub-study treatment arm.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial)	From date of registration to progression or treatment discontinuation, up to 2 years and 10 months.	Eligible and evaluable participants.	percentage of participants	NUMBER
SECONDARY	Duration of Response Among Participants Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1	From date of registration to maximum of 2 years and 10 months or death	Evaluable and eligible participants that achieved complete or partial response. 1 participant died without evidence of progression at 12 months.	months	MEAN
SECONDARY	Overall Survival With Investigational Therapy	From date of registration to maximum of 2 years and 10 months or death	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Progression-free Survival With Palbociclib.	From date of registration to maximum of 2 years and 10 months or death	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death	Participants who received at least one dose of palbociclib treatment.	Participants	NUMBER
OTHER_PRE_SPECIFIED	Screen Success Rate, Monitored by the Percentage of Screened Patients That Register to a Therapeutic Sub-study	Up to 3 years
OTHER_PRE_SPECIFIED	Treatment Arm Randomization Acceptance Rate, Monitored by the Percentage of Patients That Receive at Least One Dose of the Treatment They Are Randomized to	Up to 3 years

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial)	Palbociclib		6	95% Confidence Interval 0 to 15	percentage of participants
Duration of Response Among Participants Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1	Palbociclib		10.0	Full Range 7.70 to 12.0	months
Overall Survival With Investigational Therapy	Palbociclib		7.1	95% Confidence Interval 4.2 to 12.5	months
Progression-free Survival With Palbociclib.	Palbociclib		1.7	95% Confidence Interval 1.6 to 2.9	months
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Palbociclib	Anemia	4		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Palbociclib	Anorexia	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Palbociclib	Aspartate aminotransferase increased	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Palbociclib	Dyspnea	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Palbociclib	Fatigue	5		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Palbociclib	Febrile neutropenia	1		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Palbociclib	31
Overall Study	STARTED	Docetaxel	10
Overall Study	Participants Re-registered to Palbociclib After Progression on Docetaxel	Palbociclib	0
Overall Study	Participants Re-registered to Palbociclib After Progression on Docetaxel	Docetaxel	1
Overall Study	COMPLETED	Palbociclib	0
Overall Study	COMPLETED	Docetaxel	0
Overall Study	NOT COMPLETED	Palbociclib	31
Overall Study	NOT COMPLETED	Docetaxel	10

Source ClinicalTrials.gov

Adverse events302

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Palbociclib	19	32
other	Anemia	Blood and lymphatic system disorders	Docetaxel	7	10
other	Febrile neutropenia	Blood and lymphatic system disorders	Palbociclib	1	32
other	Febrile neutropenia	Blood and lymphatic system disorders	Docetaxel	1	10
other	Atrial fibrillation	Cardiac disorders	Palbociclib	1	32
other	Atrial fibrillation	Cardiac disorders	Docetaxel	3	10
other	Palpitations	Cardiac disorders	Palbociclib	1	32
other	Palpitations	Cardiac disorders	Docetaxel	0	10
other	Sinus tachycardia	Cardiac disorders	Palbociclib	1	32
other	Sinus tachycardia	Cardiac disorders	Docetaxel	1	10

1 to 10 of 302Source ClinicalTrials.gov

See all 302 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Palbociclib	28	32
Total, all-cause mortality	Docetaxel	10	10
Total, other adverse events	Palbociclib	31	32
Total, other adverse events	Docetaxel	10	10
Total, serious adverse events	Palbociclib	14	32
Total, serious adverse events	Docetaxel	0	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Palbociclib vs Docetaxel: deaths from any cause	Trial comparisons
Palbociclib vs Docetaxel: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02785939

GET https://conductscience.org/api/trials/v1/NCT02785939/events?page=2

API reference For AI assistants