Clinical trial · Interventional

A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

A Randomized, Open-label, Controlled, Multicenter Phase 3 Trial of HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation.

NCT07822542CI-TRIAL-00126369not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma, Non-Small-Cell Lung	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
Adebrelimab	Drug	Adebrelimab	ALIAS
Carboplatin	Drug	Carboplatin	ALIAS
Cisplatin	Drug	Cisplatin	ALIAS
HS-10370	Drug	—	UNRESOLVED
Pemetrexed	Drug	Pemetrexed	ALIAS
Tislelizumab	Drug	Tislelizumab	ALIAS

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Arm A: HS-10370 plus Adebrelimab plus chemotherapy
interventionNames
1. Drug: HS-10370
2. Drug: Adebrelimab
3. Drug: Cisplatin
4. Drug: Carboplatin
5. Drug: Pemetrexed
type
ACTIVE_COMPARATOR
label
Arm B: Tislelizumab plus chemotherapy
interventionNames
1. Drug: Cisplatin
2. Drug: Carboplatin
3. Drug: Pemetrexed
4. Drug: Tislelizumab
type
OTHER
label
Arm C: HS-10370 plus chemotherapy
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Participants are able to comply with the process of the protocol.
* Men or women greater than or equal to 18 years
* At least one measurable lesion in accordance with RECIST 1.1
* Must have an ECOG performance status of 0 or 1.
* Must have adequate laboratory parameters.
* Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
* Documentation of the presence of a KRAS G12C mutation
* Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.

Exclusion Criteria:

* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
* Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
* Active brain metastases.
* Participants with uncontrolled pleural, ascites or pericardial effusion
* History of other primary malignancies.
* Abnormal cardiac examination results.
* Severe, uncontrolled or active cardiovascular disorders.
* Uncontrolled hypertension.
* Severe bleeding symptoms or bleeding tendencies.
* Severe arteriovenous thrombosis occurred
* Serious infection.
* Continuous use of glucocorticoids
* Active infectious diseases.
* Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
* Interstitial lung disease (ILD).
* Serious neurological or mental disorders.
* Active autoimmune diseases.

References

Publications (0)

Data not yet available

No reference posted for this study.