RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Sotorasib for Non-Small Cell Lung Cancer (NSCLC)

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Official registry: https://clinicaltrials.gov/study/NCT05920356 · Amgen · enrollment listed as 750

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sotorasib, or Pembrolizumab. The registry lists allocation as randomized. The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

They plan to enroll about 750 people at 417 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Interventions: Sotorasib, Pembrolizumab

Primary outcome (registry wording): Progression-free Survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to 100 Years
Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
No history of systemic anticancer therapy in metastatic/non-curable settings
Eastern Cooperative Oncology Group (ECOG) ≤ 1

Who the registry excludes

Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
Symptomatic (treated or untreated) brain metastases
Gastrointestinal (GI) tract disease causing the inability to take oral medication
Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
Prior therapy with a KRAS G12C inhibitor

Public study contact (from the registry)

Amgen Call Center

866-572-6436

medinfo@amgen.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

417 listed

Sansum Clinic — Santa Barbara, California (recruiting)
Medical Oncology Hematology Consultants Helen F Graham Cancer Center — Newark, Delaware (recruiting)
Boca Raton Clinical Research Coral Springs — Coral Springs, Florida (recruiting)
Regis Clinical Research LLC — Miami, Florida (recruiting)
Florida Clinical Trials Group Tamarac — Tamarac, Florida (recruiting)
University of Illinois Chicago — Chicago, Illinois (recruiting)
Illinois Cancer Specialists — Niles, Illinois (recruiting)
Medical University of South Carolina — Waterloo, Iowa (recruiting)
Norton Cancer Institute - Brownsboro — Louisville, Kentucky (completed)
Reliant Medical Group Inc — Worcester, Massachusetts (recruiting)
University of New Mexico Cancer Center — Albuquerque, New Mexico (recruiting)
Memorial Sloan Kettering Cancer Center — New York, New York (terminated)

+ 390 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Evaluation for NCI Surgery Branch Clinical Research Protocols

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.

NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Collection of Blood From Patients With Cancer

This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.

NCT00034216 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phasePittsburgh, Pennsylvania

Not a traditional drug phase: Biopsy of the major carinal area for Lung Cancer

The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.

NCT00280202 · Official ClinicalTrials.gov record · University of Pittsburgh

FAQ about this NCT record

Is NCT05920356 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05920356?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05920356?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary