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
NCT ID: NCT04924192
Last Updated: 2021-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
126 participants
INTERVENTIONAL
2021-08-18
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
TQB3616 capsules
A CDK4/6 kinase inhibitor
Anlotinib Hydrochloride capsules
A multi-target receptor tyrosine kinase inhibitor
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.
TQB3616 capsules
A CDK4/6 kinase inhibitor
Irinotecan Hydrochloride for Injection
An inhibitor of DNA topoisomerase Ⅰ
Interventions
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TQB3616 capsules
A CDK4/6 kinase inhibitor
Anlotinib Hydrochloride capsules
A multi-target receptor tyrosine kinase inhibitor
Irinotecan Hydrochloride for Injection
An inhibitor of DNA topoisomerase Ⅰ
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Subjects with measurable lesions as defined by RECIST 1.1.
5. Aged ≥ 18 years ; Eastern Cooperative Oncology Group (ECOG) score: 0 \~ 1; Expected survival ≥ 3 months.
6. Laboratory indicators meet the requirements.
7. Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.
8. Subjects voluntarily joined the study and signed the informed consent form.
Exclusion Criteria
2. Cohort 2: Subjects with epidermal growth factor receptor(EGFR) mutation and anaplastic lymphoma kinase(ALK) translocation.
3. Subjects with central squamous cell carcinoma with a risk of hemoptysis.
4. 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.
5. Subjects who have brain metastases with symptoms or control of symptoms for less than 2 months.
6. Subjects with difficulty taking oral medication.
7. Subjects with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
8. Subjects with spinal cord compression who have failed to be cured or relieved by surgery and or radiotherapy.
9. Subjects who have received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks prior to the first dose of the drug.
10. Subjects who have not recovered to ≤ CTCAE Grade 1 (excluding alopecia) due to the adverse event of prior therapy.
11. Subjects with significant surgery or significant traumatic injury within 28 days before randomization.
12. Subjects with arterial/venous thrombosis within 6 months.
13. Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.
14. Subjects with any severe and/or uncontrolled disease.
15. Subjects whose large vessels are involved by tumor from imaging (CT or MRI).
16. Subjects who have hemoptysis and maximum daily hemoptysis ≥ 2.5ml within 1 month before the first dose.
17. Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.
\-
18 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdou, Sichuan, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQB3616-ALTN-II-01
Identifier Type: -
Identifier Source: org_study_id
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