Loading clinical trials...

RECRUITINGPHASE2

To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC)

A Single-arm Pilot Study of Patients With Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC) With KEAP1 Mutation Treated With Carbonizumab Combined With Chemotherapy as the First-line Treatment

NCT06341660•Guangzhou Institute of Respiratory Disease

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as first-line treatment in patients with KeAP1-mutated advanced or postoperative recurrent non-small cell lung cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures.
•2. Age ≥18 years old and ≤75 years old when signing ICF.
•3. histologically or cytologically confirmed advanced or postoperative recurrent non-small cell lung cancer (AJCC 8th edition).
•4. STK11 mutations were detected by NGS, and no other sensitive mutations could be targeted therapy (including EGFR, ALK, ROS1, RET, c-Met, HER2, BRAF gene rearrangement, fusion, amplification, and skipping).
•5. The patient had not received systemic antitumor therapy.
•6. Patients who had received one prior chemotherapy regimen were allowed, regardless of whether chemotherapy was administered before, after, or concurrently with targeted therapy.
•7. Patients receiving adjuvant or neoadjuvant therapy were allowed if adjuvant/neoadjuvant therapy had been completed at least 12 months before diagnosis of advanced or postoperative recurrent NSCLC.
•8. The interval between the end of previous nonsystemic antitumor therapy and the start of study medication had to be 4 weeks or more. Treatment-related AE recovered to CTCAE 4.03≤ grade 1 (except grade 2 alopecia).
•9. have at least one measurable target lesion as assessed by the investigator according to iRECIST requirements within 4 weeks before enrollment.
•10. If available, patients can provide eligible tumor tissue for PD-L1 expression level measurement.
+12 more criteria

Exclusion Criteria

•1. received systemic therapy for advanced NSCLC within 4 weeks after enrollment;
•2. the subjects had a history or concurrent history of other malignant tumors (except 3.cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
•candidates for or prior recipients of organ or bone marrow transplantation. 4.uncontrollable pleural, pericardial, or ascites with appropriate interventions.

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, China

Key Dates

Start Date

May 25, 2023

Primary Completion Date

June 1, 2025

Completion Date

July 1, 2025

Last Updated

April 2, 2024

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

cadonilimab

DRUG

Contacts

zhou chengzhi, doctor

CONTACT

13560351186 doctorzcz@163.com

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)