Camrelizumab Combined With SRT/WBRT and Chemotherapy in Patients With Brain Metastases of Driven Gene-negative NSCLC

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; 1,632 are open to participants now.

This study's enrollment of 60 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Guangdong Association of Clinical Trials is the lead sponsor of 53 studies on the registry; 18 are open to participants now.

Study arms

• Experimental
  Camrelizumab group

  subject will receive Camrelizumab intravenously(IV) PLUS pemetrexed or paclitaxel or albumin paclitaxel PLUS cisplatin or carboplatin AUC 5 on Day 1 of each 3-week cycle(Q3W) for 4-6 cycles followed by Camrelizumab ± pemetrexed IV Q3W until progression (up to approximately 2 years). Whether the subject accepts intracranial radiotherapy will be decided by investigators according to the guidelines and the conditions of the subjects.

  Drug: Camrelizumab · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Albumin paclitaxel

• Placebo comparator
  placebo group

  subject will receive placebo intravenously (IV) PLUS pemetrexed or paclitaxel or albumin paclitaxel PLUS cisplatin or carboplatin AUC 5 on Day 1 of each 3-week cycle(Q3W) for 4-6 cycles followed by placebo ± pemetrexed IV Q3W until progression (up to approximately 2 years). Whether the subject accepts intracranial radiotherapy will be decided by investigators according to the guidelines and the conditions of the subjects.

  Drug: Placebo · Drug: Cisplatin · Drug: Carboplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Albumin paclitaxel

Interventions

• DrugCamrelizumab

  Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody

  Also known as: SHR-1210

• DrugPlacebo

  IV infusion Simulator of Camrelizumab

  Also known as: Simulator of Camrelizumab

• DrugCisplatin

  IV infusion

  Also known as: cisplatinum

• DrugCarboplatin

  IV infusion

  Also known as: Carboplat

• DrugPemetrexed

  IV infusion

  Also known as: Pemetrexed disodium

• DrugPaclitaxel

  IV infusion

  Also known as: Paclitaxel injection

• DrugAlbumin paclitaxel

  IV infusion

  Also known as: Nab-paclitaxel

Primary outcomes

1. Intracranial Progression-Free Survival(iPFS)

   Intracranial Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression in brain metastasis disease or death from any cause or switch therapy

   Time frame: up to 24 months

2. Progression-Free Survival (PFS)

   PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

   Time frame: up to 24 months

Secondary outcomes

1. Intracranial Objective Response Rate (iORR)

   iORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response(PR: ≥30% decrease in the sum of diameters of target lesions) in brain lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

   Time frame: up to 24 months

2. Objective Response Rate (ORR)

   ORR was defined as the percentage of participants in the analysis population who had a CR or a PR.

   Time frame: up to 24 months

3. Intracranial Duration of Response (iDOR)

   iDOR was defined as the time from first documented evidence of a CR or PR until PD or death

   Time frame: up to 24 months

4. Overall Survival (OS)

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

   Time frame: up to death

5. Duration of Response (DOR)

   DOR was defined as the time from first documented evidence of a CR or PR until PD or death

   Time frame: up to 24 months

6. Adverse events (AEs)/ Serious adverse event (SAE)

   All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0

   Time frame: up to 24 months

7. Mini-Mental State Examination (MMSE)

   Assessment of cognitive function using the Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, registration, attention and calculation, recall, and language. Total scores range from 0 to 30, with higher scores indicating better cognitive function.

   Time frame: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months

8. Hopkins Verbal Learning Test - Revised (HVLT-R)

   Assessment of verbal learning and memory using the Hopkins Verbal Learning Test - Revised (HVLT-R). The HVLT-R consists of three learning trials of a 12-word list, a delayed recall trial, and a delayed recognition trial. Total recall score (trials 1-3) ranges from 0 to 36, delayed recall score from 0 to 12, and recognition discrimination index from -12 to 12. Higher scores indicate better verbal learning and memory function.

   Time frame: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months

Other outcomes

1. Change in Functioning Scales (EORTC QLQ-C30)

   Change from baseline in patient-reported global health status/quality of life, as measured by the EORTC QLQ-C30 global health status/QoL scale. Scores are transformed to a 0-100 scale; higher scores indicate better quality of life.

   Time frame: Assessed at baseline and at each scheduled tumor imaging assessment (every 6 weeks for the first 48 weeks, then every 12 weeks thereafter) up to 24 months

Publications

• Li YS, Yu Q, Bu Q, Lin L, Ning F, Zhao Y, Wu G, Lin G, Zang A, Sun H, Huang J, Tu HY, Ma S, Zhou C, Liu A, Wang C, Yao Y, Han G, Zhao J, Zhou Q, Yan HH, Liu SM, Zheng MM, Lv J, Cheng F, Chen Z, Zhong WZ, Pan Y, Yang JJ, Wu YL. First-Line Camrelizumab Versus Placebo Plus Chemotherapy With or Without Radiotherapy for Brain Metastases in NSCLC: The CTONG 2003 Randomized Placebo-Controlled Trial. J Thorac Oncol. 2025 Jul;20(7):928-940. doi: 10.1016/j.jtho.2025.02.004. Epub 2025 Feb 8. PubMed 39929333 ↗

Study documents

• Study protocol · May 12, 2023
• Statistical analysis plan · Feb 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No