A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients

NCT06335355 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1316-307
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Investigator-assessed Objective Response Rate (Phase One)

  about 3 years

• Overall Survival (Phase Two)

  about 3.5 years

Secondary Outcomes (6)

• The incidence and severity of Adverse Events (AEs) (Phases One and Two)

  about 4.5 years

• Duration of Response (DoR) based on Investigator Assessment (Phases One and Two)

  about 6.5 years

• Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two)

  about 6.5 years

• Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two)

  about 6.5 years

• Overall Survival (OS) (Phase One)

  about 3.5 years

Study Arms (3)

Treatment group A

EXPERIMENTAL

Drug: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin

Treatment group B

ACTIVE COMPARATOR

Drug: Camrelizumab + Pemetrexed + Carboplatin

Treatment group C

ACTIVE COMPARATOR

Drug: Adebrelimab + Pemetrexed + Carboplatin

Interventions

Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin DRUG

Adebrelimab,1200mg; SHR-8068, 1.0 mg/kg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

Treatment group A

Camrelizumab + Pemetrexed + Carboplatin DRUG

Camrelizumab,200mg;Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

Treatment group B

Adebrelimab + Pemetrexed + Carboplatin DRUG

Adebrelimab,1200mg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

Treatment group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.
• At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.
• Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.
• At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .
• The participant is expected to have a life expectancy of at least 12 weeks.
• Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed.
• The participant must have adequate bone marrow and organ function.

You may not qualify if:

• Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.
• Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.
• Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
• Subjects with inadequately controlled pain related to their tumor(s).
• Subjects with a history of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ following mastectomy (allowing for hormonal treatment for non-metastatic prostate or breast cancer), and papillary thyroid cancer which have achieved complete remission for at least 5 years prior to screening and do not require or are not expected to require further treatment during the study period.
• Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior to initiating the study treatment.
• Subjects whose toxicities and/or complications from previous interventions have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) Grade ≤1.
• Subjects participating in another clinical study or whose initiation of study treatment is less than 4 weeks since the end of the last clinical study (last dose administration), or less than five half-lives of that study drug, whichever is shorter.
• Subjects who have received systemic immunostimulant treatment within 4 weeks prior to starting the study treatment.
• Subjects who have received systemic immunosuppressive treatment within 2 weeks prior to starting the study treatment.
• Subjects with any active, known, or suspected autoimmune disease.
• Subjects with severe heart disease.
• Subjects who have experienced arterial or venous thrombotic events within 3 months prior to starting the study treatment.
• Subjects with active syphilis infection.
• Subjects who have had a severe infection within 4 weeks prior to starting the study treatment.

Sponsors & Collaborators

• Shanghai Shengdi Pharmaceutical Co., Ltd: lead

Study Sites (1)

Affiliated Tumor Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location

MeSH Terms

Interventions

Pemetrexed; Carboplatin; camrelizumab

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Central Study Contacts

Junli Qang

CONTACT

+0518-81220121; Junli.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CN (1)