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Combination Therapy of Sintilimab and Anlotinib as a First-line Treatment in Advanced NSCLC (SUNRISE)

NCT04124731 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-10-11

No results posted yet for this study

Summary

This is an open label, multi-center, randomized control phase II trial, to compare the efficacy and safety of sintilimab combined with anlotinib versus standard platinum-based chemotherapy as a first-line treatment in advanced NSCLC patients without driven-gene mutations.

Conditions

Interventions

DRUG

sintilimab plus anlotinib

Sintilimab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21

DRUG

Chemotherapy

1. Pemetrexed combined with platinum regimen (non-squamous cell carcinoma): pemetrexed 500mg/m2, intravenous infusion on the first day of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on the first day of each cycle, 1 cycle every 3 weeks (Q3W), 4 cycles in total. Patients who did not progress after 4 cycles received maintenance monotherapy with pemetrexide at the same dose as before. 2. Gemcitabine combined with platinum regimen (squamous cell carcinoma): gemcitabine 1250mg/m2, intravenous infusion on day 1 and day 8 of each cycle, cisplatin: 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, 1 cycle every 3 weeks (Q3W), 4-6 cycles in total.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2021-04-30
Completion
2022-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04124731 on ClinicalTrials.gov