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Small Molecule Drug
Divarasib + Pembrolizumab for Non-Small Cell Lung Cancer (Krascendo 170 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called divarasib along with other cancer treatments. It focuses on people with advanced or metastatic non-small cell lung cancer. The study aims to see how divarasib moves through the body, its safety, and if it helps fight the cancer.
Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that hasn't been treated yet and has a specific mutation called KRAS G12C. Participants need to have measurable disease, be in good physical condition (ECOG 0 or 1), and provide tumor tissue samples. They can't join if they've had another cancer within the last 5 years, untreated brain metastases, uncontrolled symptoms from their cancer, prior treatment with KRAS G12C inhibitors, certain lung conditions, active infections like TB, or recent heart problems.
What is being tested?
The study tests Divarasib combined with other anti-cancer drugs: Pemetrexed, Cisplatin/Carboplatin and Pembrolizumab in patients who haven’t received any previous treatments for their NSCLC. It aims to assess how safe this combination is and how it affects the body (pharmacokinetics) as well as its effectiveness against the cancer.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation of organs; infusion-related reactions; fatigue; nausea; blood count changes which could lead to increased infection risk; kidney function changes due to chemotherapy agents like Cisplatin/Carboplatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Duration of Response (DOR)
Identification of Divarasib Recommended Dose
Objective Response Rate (ORR)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B - Combination Dose Finding + Dose ExpansionExperimental Treatment5 Interventions
Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
Group II: Cohort A - Combination Dose Finding + Dose ExpansionExperimental Treatment2 Interventions
Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).
During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Divarasib
2021
Completed Phase 1
~430
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Pemetrexed
2014
Completed Phase 3
~5550
Pembrolizumab
2017
Completed Phase 3
~3130
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as those inhibiting KRAS G12C mutations (e.g., sotorasib and adagrasib), work by specifically blocking the molecular pathways that drive cancer cell growth and survival.
Immunotherapies, like pembrolizumab, enhance the body's immune response against cancer cells by targeting immune checkpoints. Chemotherapy, using agents like cisplatin and paclitaxel, kills rapidly dividing cells, including cancer cells, but also affects normal cells.
These treatments are crucial for NSCLC patients as they offer personalized and effective options, especially for those with specific genetic mutations, leading to better outcomes and potentially fewer side effects compared to traditional chemotherapy.
Emerging therapeutic agents for lung cancer.
Emerging therapeutic agents for lung cancer.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,460 Previous Clinical Trials
1,097,802 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,230 Previous Clinical Trials
897,158 Total Patients Enrolled