A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT04924192
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TQB3616 capsules — DRUG
    A CDK4/6 kinase inhibitor
  • Anlotinib Hydrochloride capsules — DRUG
    A multi-target receptor tyrosine kinase inhibitor
  • Irinotecan Hydrochloride for Injection — DRUG
    An inhibitor of DNA topoisomerase Ⅰ

Study Details

This is an open, multi-cohort, exploratory phase II study on the safety and efficacy of TQB3616 combined with Anlotinib hydrochloride capsules or standard chemotherapy in the treatment of advanced lung cancer.

Key Dates

Start date
Aug 18, 2021
Status verified
Apr 2026
Primary completion
Sep 27, 2022
Completion
Oct 10, 2022

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB3616 capsules+Anlotinib hydrochloride capsules
    TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 21 consective days as a treatment cycle;Anlotinib hydrochloride capsules 12mg, once a day for 2 consecutive weeks and stop for 1 week.
  • Experimental: TQB3616 capsules +Irinotecan Hydrochloride for Injection
    TQB3616 capsules 120/150/180mg orally on an empty stomach, once a day for 28 consecutive days as a treatment cycle. Irinotecan Hydrochloride Injection 100 mg/m2 intravenous infusion on D1、D8 and D15, a total of 4-6 cycles.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: up to 96 weeks ]

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