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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    126
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 7 July 2021

Summary

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.

Details
Condition Advanced Lung Carcinoma
Treatment Anlotinib Hydrochloride Capsules, TQB3616 capsules, Irinotecan Hydrochloride for Injection
Clinical Study IdentifierNCT04924192
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on7 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects with pathologically proven small cell lung cancer(SCLC) or/and locally advanced ( Stage B/ C), metastatic or recurrent (Stage IV) non small cell lung cancer(NSCLC)
Cohort 1: Subjects with SCLC who had previously received at least one chemotherapy containing platinum or got disease progression during chemoradiotherapy or after the last treatment
Cohort 2: Subjects with locally advanced, metastatic/relapsed NSCLC who had previously received only one PD (L) 1 inhibitor alone or in combination with platinum-based chemotherapy
Subjects with measurable lesions as defined by RECIST 1.1
Aged 18 years ; Eastern Cooperative Oncology Group (ECOG) score: 0 ~ 1; Expected survival 3 months
Laboratory indicators meet the requirements
Non-pregnant or non-breastfeeding women; Negative pregnancy subjects
Subjects voluntarily joined the study and signed the informed consent form

Exclusion Criteria

Subjects who received prior therapy with anlotinib hydrochloride capsules
Cohort 2: Subjects with epidermal growth factor receptor(EGFR) mutation and anaplastic lymphoma kinase(ALK) translocation
Subjects with central squamous cell carcinoma with a risk of hemoptysis
Subjects who have developed or is currently suffering from other malignancies within 5 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ
Subjects who have brain metastases with symptoms or control of symptoms for less than 2 months
Subjects with difficulty taking oral medication
Subjects with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
Subjects with spinal cord compression who have failed to be cured or relieved by surgery and or radiotherapy
Subjects who have received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks prior to the first dose of the drug
Subjects who have not recovered to CTCAE Grade 1 (excluding alopecia) due to the adverse event of prior therapy
Subjects with significant surgery or significant traumatic injury within 28 days before randomization
Subjects with arterial/venous thrombosis within 6 months
Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders
Subjects with any severe and/or uncontrolled disease
Subjects whose large vessels are involved by tumor from imaging (CT or MRI)
Subjects who have hemoptysis and maximum daily hemoptysis 2.5ml within 1 month before the first dose
Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator
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