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NCT05789082 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or 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

A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 1
Development phase
320
Enrollment target
20
Study locations

NCT05789082 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 320 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT05789082, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 1
Development phase
320 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Pemetrexed
  • DRUG Divarasib

Study Locations (20)

California

  • City of Hope National Medical Center - Duarte
  • City of Hope - Seacliff - Huntington Beach
  • City of Hope at Irvine Lennar - Irvine
  • UCSD Moores Cancer Center - La Jolla
  • City of Hope - Long Beach Elm - Long Beach

New York

  • NYU Langone Hospital - Long Island - Mineola
  • NYU Cancer Center - New York
  • Mount SInai Medical Center - New York
  • Montefiore Medical Center - Montefiore Medical Park - The Bronx

Florida

  • Florida Cancer Specialists - SOUTH - SCRI - PPDS - Fort Myers
  • Florida Cancer Specialists - NORTH - SCRI - PPDS - St. Petersburg
  • Florida Cancer Specialists - EAST - SCRI - PPDS - West Palm Beach

Other

  • Hospital Britanico - Buenos Aires
  • Clinica Adventista Belgrano - Ciudad Autonoma Buenos Aires
  • Centro Oncologico Riojano Integral (CORI) - La Rioja

Virginia

  • Oncology & Hematology Associates of Southwest Virginia, Inc - Blacksburg
  • Virginia Oncology Associates - Norfolk

Connecticut

  • Yale Cancer Center - New Haven

Texas

  • MD Anderson Cancer Center - Houston

New South Wales

  • Concord Repatriation General Hospital - Concord

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2023-06-20
Est. Completion 2032-01-29
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT05789082

The ClinicalTrials.gov registry entry for NCT05789082 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (51% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05789082 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT05789082 about?

NCT05789082 is a clinical study titled "A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or 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". The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

What is the current status of trial NCT05789082?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2023-06-20. Estimated completion is 2032-01-29.

What conditions does trial NCT05789082 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT05789082?

The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Divarasib (DRUG).

Who is sponsoring clinical trial NCT05789082?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05789082 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.