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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

Krascendo 170 Trial Summary

This trial tests a new drug to safely treat advanced or metastatic non-small cell lung cancer in people with no prior treatment.

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.Check my eligibility

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.See study design

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.

Krascendo 170 Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AEs)

Secondary outcome measures

Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE

Duration of Response (DOR)

Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)

+7 more

Krascendo 170 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

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Pemetrexed

2014

Completed Phase 3

~5250

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,127 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,844 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this experiment open currently?

"Confirmed. In accordance with the information available on clinicaltrials.gov, this study is actively recruiting for volunteers and was initially posted on June 20th of 2023; it has since been updated to reflect new developments as recently as November 8th of the same year. The trial requires 60 patients from 24 sites in total."

Answered by AI

How many venues are employed for this experiment?

"This investigation is being conducted in multiple locations, including Jessa Zkh (Campus Virga Jesse) in Hasselt, Barcelona; ICO Badalona-H.U. Germans Trias i Pujol in Badalona, Victoria; and Vall d?Hebron Institute of Oncology (VHIO), Barcelona located within the capital city of Spain. Additionally, there are 21 other sites hosting this clinical trial."

Answered by AI

How many individuals are participating in this research project?

"Hoffmann-La Roche is sponsoring this trial and requires 60 participants that meet the study's criteria. Three different sites will be utilized for data collection: Jessa Zkh (Campus Virga Jesse) in Hasselt, Barcelona, and ICO Badalona-H.U. Germans Trias i Pujol in Badalona, Victoria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

2023. "A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05789082.