Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Summary

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Conditions

• Recurrent Squamous Cell Lung Carcinoma
• Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions

DRUG

Docetaxel

Given IV

BIOLOGICAL

Durvalumab

Given IV

DRUG

Erlotinib Hydrochloride

Given PO

DRUG

FGFR Inhibitor AZD4547

Given PO

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

DRUG

Palbociclib

Given PO

OTHER

Pharmacological Study

Correlative studies

BIOLOGICAL

Rilotumumab

Given IV

DRUG

Talazoparib

Given PO

DRUG

Taselisib

Given PO

BIOLOGICAL

Tremelimumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Vassiliki Papadimitrakopoulou · SWOG Cancer Research Network

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-08

Primary Completion

2022-04-01

Completion

2022-04-15

FDA Device

Yes

Countries

• United States
• Canada

Study Locations