A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF GDC-6036 IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATIO
- Conditions
- ON-SMALL CELL LUNG CANCER MET EEN KRAS G12C MUTATIONNON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATIO
- Registration Number
- NL-OMON53747
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
- 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
- Confirmation of Biomarker eligibility:
.. Documented history of the KRAS G12C mutation
.. Documented history of PD-L1 tumor cell expression >=1%
- 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
- Measurable disease, as defined by Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1
- 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 GDC-6036 or pembrolizumab
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Occurrence of adverse events<br /><br>2. Change from baseline at each visit in targeted safety parameters</p><br>
- Secondary Outcome Measures
Name Time Method