NCT06883136

Efficacy and Safety of Sintilimab Combined with Platinum-containing Double-agent Chemotherapy in First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Elderly Patients

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 43 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of sindilizumab combined with platinum-containing dual chemotherapy in first-line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This study was an observational, prospective, single-arm, single-center study. Specific dosing regimens are as follows: 1. Sintilimab, 200mg, intravenous infusion on day 1 of each cycle, every 3 weeks as a cycle (Q3W), until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol; The longest treatment time of sintilimab was 24 months. 2. Chemotherapy regimen: 1\) Pemetrexed combined with platinum regimen (non-squamous cell carcinoma) : pemetrexed 500mg/m2, intravenous infusion on day 1 of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for a total of 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance pemetrexed monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons. 2\) Gemcitabine plus platinum regimen (squamous cell carcinoma) : gemcitabine 1000mg/m2 intravenously on days 1 and 8 of each cycle, cisplatin 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance gemcitabine monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons. Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 5.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline.

Detailed description

To investigate the efficacy and safety of sindilizumab combined with platinum-containing dual chemotherapy in first-line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This study was an observational, prospective, single-arm, single-center study. Specific dosing regimens are as follows: 1. Sintilimab, 200mg, intravenous infusion on day 1 of each cycle, every 3 weeks as a cycle (Q3W), until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol; The longest treatment time of sintilimab was 24 months. 2. Chemotherapy regimen: 1\) Pemetrexed combined with platinum regimen (non-squamous cell carcinoma) : pemetrexed 500mg/m2, intravenous infusion on day 1 of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for a total of 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance pemetrexed monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons. 2\) Gemcitabine plus platinum regimen (squamous cell carcinoma) : gemcitabine 1000mg/m2 intravenously on days 1 and 8 of each cycle, cisplatin 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance gemcitabine monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons. Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 5.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab+Cis-platinum/Carboplatin with Pemetrexed or Gemcitabine	1. Sintilimab, 200mg, intravenous infusion on day 1 of each cycle, every 3 weeks as a cycle (Q3W), until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol; The longest treatment time of sintilimab was 24 months. 2. Chemotherapy regimen: 1\) Pemetrexed combined with platinum regimen (non-squamous cell carcinoma) : pemetrexed 500mg/m2, intravenous infusion on day 1 of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for a total of 4-6 cycles. 2\) Gemcitabine plus platinum regimen (squamous cell carcinoma) : gemcitabine 1000mg/m2 intravenously on days 1 and 8 of each cycle, cisplatin 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for 4-6 cycles.

Timeline

• Start date: 2025-03-12
• Primary completion: 2026-05-30
• Completion: 2027-06-29
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

2 sites across 1 country: China