JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation
Recruiting
Phase 3Interventional Study
Advanced Non-squamous Non-small-cell Lung CancerMetastatic Non-squamous Non Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
392 (estimated)
Sponsor
Allist Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced non-small cell lung cancer who have a specific mutation. Participants will receive new treatments to see how well they work compared to standard care.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced non-small cell lung cancer with a KRAS G12C mutation.
I have not received any treatment for my advanced cancer.
I expect to live at least 3 more months.
I have at least one tumor that can be measured.
My health is rated as ECOG 1 or lower.
You may not be able to join if
I have had other types of cancer in the last 2 years.
I have other gene mutations that can be treated.
I have untreated brain metastases.
I have uncontrolled fluid buildup in my chest, heart sack, or abdomen.
I have significant heart problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* A signed written informed consent is required before performing any study-related operations
* Age greater than or equal to 18 years old
* Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirme…
Inclusion Criteria:
* A signed written informed consent is required before performing any study-related operations
* Age greater than or equal to 18 years old
* Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
* No history of systemic anticancer therapy to the local advanced/metastatic disease
* Expected survival period greater than or equal to 3 months
* Having at least one target lesion according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
Exclusion Criteria:
* Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types
* Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
* Subjects with untreated central nervous system (CNS) metastases were excluded;
* Uncontrolled pleural effusion, pericardial effusion, and ascites
* Subjects with impaired heart function or clinically significant heart disease
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