Advanced Non-Small Cell Lung Cancer study: Adagrasib vs Pembrolizumab
Official title Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
ClinicalTrials.gov ID: NCT04613596
What this study is testing
What is Adagrasib plus Pembrolizumab?
This is an investigational combination of two medicines being studied as a potential treatment for advanced non-small cell lung cancer. Adagrasib is designed to block a specific protein change in cancer cells, while pembrolizumab is designed to help the immune system recognize and attack cancer cells.
Also referred to as MRTX849, Keytruda.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new drug works well and is safe. It also checks if adding it to another drug helps more than the second drug alone.
- Who it's for
- You may be able to join if you have advanced lung cancer with a KRAS G12C gene change.
- What's involved
- You would take a new medicine called adagrasib. You might also get a drug called pembrolizumab. You would get regular check-ups and tests.
- Time commitment
- The study lasts for a long time with regular visits to the clinic.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
- Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
- Phase 3: Presence of measurable disease per RECIST1.1
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy
You likely can't join if
- Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy...
- Phase 2: Active brain metastases
- Any untreated brain lesions \> 2.0 cm in size
- Any brainstem lesions
- Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent)...
- Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding...
See the full eligibility criteria
- Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
- Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
- Phase 3: Presence of measurable disease per RECIST1.1
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy
- Previously treated brain metastases not needing immediate local therapy
- Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Phase 2: Active brain metastases
- Any untreated brain lesions \> 2.0 cm in size
- Any brainstem lesions
- Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization.
- Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
- Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment
The study team makes the final eligibility decision.
Where it is enrolling
- Prescott Valley, Arizona, United States
- Tucson, Arizona, United States
- Springdale, Arkansas, United States
- Anaheim, California, United States
- Cerritos, California, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- San Francisco, California, United States
- Santa Rosa, California, United States
- Stockton, California, United States
- Lone Tree, Colorado, United States
- Norwich, Connecticut, United States
- Aventura, Florida, United States
- Bay Pines, Florida, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Tallahassee, Florida, United States
+ 310 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Prescott Valley, Arizona, United States; Tucson, Arizona, United States; Springdale, Arkansas, United States; Anaheim, California, United States; Cerritos, California, United States; Long Beach, California, United States and 324 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.