Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,488

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 460 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.

Study arms

• Experimental
  SHR-8068，adebelizumab and platinum-based chemotherapy

  Drug: SHR-8068，adebelizumab and platinum-based chemotherapy

• Active comparator
  tislelizumab, and platinum-based chemotherapy

  Drug: tislelizumab, and platinum-based chemotherapy

Interventions

• DrugSHR-8068，adebelizumab and platinum-based chemotherapy

  SHR-8068，adebelizumab and platinum-based chemotherapy

• Drugtislelizumab, and platinum-based chemotherapy

  tislelizumab, and platinum-based chemotherapy

Primary outcomes

1. Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]

   PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)

   Time frame: Approximately 32 months.

2. OS

   OS was defined as the time from the date of randomization until death due to any cause.

   Time frame: Approximately 64 months.

Secondary outcomes

1. PFS by the investigator

   PFS (per RECIST 1.1) by the investigator was defined as time from date of randomization until date of objective disease or death (by any cause in the absence of progression)

   Time frame: Approximately 32 months.

2. Objective Response Rate (ORR)

   ORR (per RECIST 1.1) by BICR or the investigator was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR).

   Time frame: Approximately 32 months.

3. Duration of Response (DoR)

   DoR (per RECIST 1.1) by BICR or the investigator was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.

   Time frame: Approximately 32 month

4. Incidence and Severity of Adverse Events (AEs)

   Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 60 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.

   Time frame: Approximately 64 months.

5. Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13)

   The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms and treatment-related symptoms from conventional chemotherapy and radiotherapy. Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.

   Time frame: Approximately 64 months.

Individual participant data

Plan to share: Undecided