RightFit
RecruitingPhase not listed

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests new drugs with pembrolizumab, either alone or with chemotherapy, for non-small cell lung cancer (NSCLC). It includes a main screening study and smaller studies for different groups of people with NSCLC.

This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage IV NSCLC, meaning lung cancer that has spread, confirmed by a tissue or cell test. Both squamous and nonsquamous types are allowed.
  • Have cancer that can be measured using the study’s rules.

Who can't join

  • Have an active autoimmune disease, where the immune system attacks the body, that needed treatment affecting the whole body in the past 2 years.
  • Have lung inflammation or scarring now, or had lung inflammation or scarring not caused by infection that needed steroid treatment.
  • Have an active infection that needs treatment affecting the whole body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC * Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy

Study sites (18)

AZ

CA

DC

KY

MA

MD

ND

NE

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) · Omaha, NE 68130More trials in Omaha

NH

NJ

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) · Hackensack, NJ 07601More trials in Hackensack

NY

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034) · New York, NY 10016More trials in New York

OH

PA

SD

TX