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Study of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous NSCLC with KRAS G12C Mutation (KRYSTAL-4)
EU CTIS ID: 2024-515698-85-00
What this study is testing
The main objective of this study is to assess the potential added benefit when Adagrasib is combined with the current standard of care treatment in patients with untreated advanced lung cancer with a KRAS G12C mutation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection)
- Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
You likely can't join if
- Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years prior to randomization..
- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
- Inadequate bone marrow function.
- Inadequate liver function.
- Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
- Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
See the full eligibility criteria
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection)
- Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
- Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years prior to randomization..
- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
- Inadequate bone marrow function.
- Inadequate liver function.
- Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
- Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
- Certain significant ECG abnormalities.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
- Evidence of active infection requiring parenteral therapy in the 2 weeks prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- India
- Thailand
- Brazil
- Saudi Arabia
- Australia
- Mexico
- Japan
- United States
- Chile
- Switzerland
- Argentina
- United Kingdom
- Turkey
- Colombia
- China
- Hong Kong
- Canada
- Israel
- Taiwan
- Korea, Republic of
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Thailand; Brazil; Saudi Arabia; Australia; Mexico and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.