Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer

Study summary

The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGDC-1971 and Osimertinib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 13, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Genentech, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Genentech, Inc.
Interventions being studied: Drug: GDC-1971; Drug: Osimertinib; Drug: Cetuximab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Evaluable or measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of ≥12 weeks
Adequate hematologic and organ function within 14 days prior to initiation of study Inclusion Criteria for Non-Small Cell Lung Cancer Cohorts
Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the lung that has progressed on/after prior treatment with third-generation epidermal growth factor receptor (EGFR) inhibitor (e.g., osimertinib)
Positive for an EGFR exon 19 deletion or exon 21 L858R mutation
Negative for acquired on-target EGFR alterations Inclusion Criteria for Colorectal Cancer Cohorts
Histologically confirmed metastatic adenocarcinoma of the colon or rectum that has progressed on/after prior treatment with an EGFR inhibitor (e.g., cetuximab or panitumumab)
Negative for kirsten rat sarcoma viral oncogene homolog (KRAS) alterations
Negative for neuroblastoma RAS viral oncogene homolog (NRAS) alterations
Negative for proto-oncogene B-Raf (BRAF) V600E alterations
In lieu of a fresh pre-treatment biopsy, a recently obtained biopsy performed after completion of osimertinib therapy will be acceptable

Reasons someone may not be able to joinExclusion criteria

Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 3 weeks or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study treatment
Treatment with endocrine therapy within 2 weeks prior to initiation of study drug, except for hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for endocrine-sensitive cancers
Significant traumatic injury or major surgical procedure within 4 weeks prior to Cycle 1, Day 1
Positive hepatitis C virus (HCV) antibody test at screening
Positive hepatitis B surface antigen (HBsAg) test at screening
Known HIV infection
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Uncontrolled hypercalcemia
Substance abuse, as determined by the investigator, within 12 months prior to screening
Poor peripheral venous access
Inability or unwillingness to swallow pills
Malabsorption syndrome or other condition that would interfere with enteral absorption Chronic diarrhea, short bowel syndrome, or significant upper GI surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)
Serious infection within 4 weeks prior to screening
History of malignancy within 3 years prior to screening
Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Leptomeningeal disease or carcinomatous meningitis
History or presence of an abnormal electrocardiogram (ECG) that is deemed clinically significant by the investigator (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence of prior myocardial infarction
Left ventricular ejection fraction (LVEF) less than the institutional lower limit of normal (LLN) or \<50%
History or evidence of ophthalmic disease
History of or active clinically significant cardiovascular dysfunction
History of pulmonary firbrosis, organizing pneumonia, or pneumonitis Other protocol-defined inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

SCRI Oncology PartnersNashville, Tennessee
START South Texas Accelerated Research Therapeutics-San AntonioSan Antonio, Texas
Border Medical OncologyWodonga, New South Wales
St Vincent's Hospital MelbourneFitzroy, Victoria
Seoul National University HospitalSeoul
Asan Medical CenterSeoul

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 13, 2025. Always confirm current availability with the study team.

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