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RecruitingLast updated: 29 November 2023

This study is evaluating how safe and effective targeted therapy is in combination with other anti-cancer therapies in people with previously untreated, advanced or metastatic non-small cell lung cancerA Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Clinical summary

Summary

This study has Dose Finding and Dose Expansion stages. Treatment cycles are 21-days.

Participants will receive one of two doses of targeted therapy (called divarasib) orally once daily combined with immunotherapy (called pembrolizumab) via intravenous (IV) infusion every three weeks on Day 1 of each cycle.

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.

Conditions

This trial is treating patients with non-small cell lung cancer who have not had prior treatment for their advanced disease

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Eligibility

Inclusion

  • Confirmation of Biomarker eligibility
  • Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • No prior systemic treatment for advanced unresectable or metastatic NSCLC
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Exclusion

  • Known concomitant second oncogenic driver with available targeted treatment
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Prior treatment with a KRAS G12C inhibitor
  • Known hypersensitivity to any of the components of divarasib or pembrolizumab
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment
  • History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
  • Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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