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CAPTAIN-1st

Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma

Phase 3N = 263NCT03707509

Population
Previously untreated recurrent or metastatic nasopharyngeal carcinoma
Design
Multicentre, randomised, double-blind phase 3 trial at 28 hospitals in China. 263 eligible patients aged 18-75 years with ECOG performance status 0-1 and previously untreated recurrent or metastatic NPC were randomly assigned 1:1 to camrelizumab 200 mg or placebo with gemcitabine (1000 mg per square metre on days 1 and 8) and cisplatin (80 mg per square metre) every 3 weeks for four to six cycles, followed by maintenance camrelizumab or placebo. The primary endpoint was progression-free survival per independent review committee.
Primary endpoint
PFS
Arms
  • Camrelizumab plus gemcitabine-cisplatin (experimental, n = 134): Camrelizumab 200 mg with gemcitabine and cisplatin for four to six cycles, then camrelizumab maintenance
  • Placebo plus gemcitabine-cisplatin (control, n = 129): Placebo with gemcitabine and cisplatin for four to six cycles, then placebo maintenance
People
Yang Y, senior author Zhang L
PFSHR 0.54 (95% CI 0.39–0.76)Δ median PFS+2.8 monthsOSHR 0.74 (95% CI 0.55–0.99)Δ median OS+7.9 monthsΔ 60-month OS+13.6 points
Show the numbers
Results reported for CAPTAIN-1st
EndpointAnalysisCamrelizumab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatinEffect
PFSRandomised patients who received at least one dose (efficacy analysis set; 263 randomised)interimYang 2021median 9.7 months (8.3–11.4)median 6.9 months (5.9–7.3)HR 0.54 (95% CI 0.39–0.76)P=0.0002 (one-sided)The significance threshold for the interim analysis was a one-sided p of 0.0086. Treatment-related deaths: five (4%) with camrelizumab and one (<1%) with placebo.
OSRandomised patients (N = 263)long term-updateHuang 2026median 34.5 months (29.4–45.7); 37.8% at 5 ymedian 26.6 months (19.8–33.5); 24.2% at 5 yHR 0.74 (95% CI 0.55–0.99)P=0.047Prespecified secondary analysis of overall survival (data analysis 1 June 2025); median survival follow-up 63.5 months (camrelizumab) and 63.0 months (placebo). After adjustment for an age imbalance, the hazard ratio was 0.65 (95% CI 0.48-0.89; P=.01). The 5-year survival difference was 13.6% (95% CI 2.4%-24.8%; P=.02).
Results reported for CAPTAIN-1st
EndpointAnalysisCamrelizumab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatinEffect
PFSRandomised patients who received at least one dose (efficacy analysis set; 263 randomised)interimYang 2021median 9.7 months (8.3–11.4)median 6.9 months (5.9–7.3)HR 0.54 (95% CI 0.39–0.76)P=0.0002 (one-sided)The significance threshold for the interim analysis was a one-sided p of 0.0086. Treatment-related deaths: five (4%) with camrelizumab and one (<1%) with placebo.
OSRandomised patients (N = 263)long term-updateHuang 2026median 34.5 months (29.4–45.7); 37.8% at 5 ymedian 26.6 months (19.8–33.5); 24.2% at 5 yHR 0.74 (95% CI 0.55–0.99)P=0.047Prespecified secondary analysis of overall survival (data analysis 1 June 2025); median survival follow-up 63.5 months (camrelizumab) and 63.0 months (placebo). After adjustment for an age imbalance, the hazard ratio was 0.65 (95% CI 0.48-0.89; P=.01). The 5-year survival difference was 13.6% (95% CI 2.4%-24.8%; P=.02).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.540.39–0.76
OS0.740.55–0.99
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%05101520Months (modelled)
  • Camrelizumab plus gemcitabine-cisplatin (experimental)
  • Placebo plus gemcitabine-cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCamrelizumab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatin
0100.0%100.0%
665.1%54.7%
1242.4%30.0%
1827.6%16.4%
2418.0%9.0%
Illustrative — modelled from reported values, not trial data. OS, long term-update.
0%25%50%75%100%020406080Months (modelled)
  • Camrelizumab plus gemcitabine-cisplatin (experimental)
  • Placebo plus gemcitabine-cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCamrelizumab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatin
0100.0%100.0%
2264.3%56.4%
4342.2%32.6%
6527.1%18.4%
8617.8%10.6%
Primary publication: Yang Y, Qu S, Li J, Hu C, Xu M, Li W, et al. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021;22(8):1162-1174. PubMedDOI

Appears in

Sources

  1. Yang Y, Qu S, Li J, Hu C, Xu M, Li W, et al. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021;22(8):1162-1174.

    PubMedDOI

  2. Huang Y, Sun D, Zhou H, Zhou T, Qu S, Li J, et al. Five-Year Outcome of Camrelizumab Plus Chemotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma: A Secondary Analysis of the CAPTAIN-1st Randomized Clinical Trial. JAMA Oncol. 2026;12(3):295-302.

    PubMedDOI