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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Lung Carcinoma
• Intervention / Treatment: Drug: TQB3616 capsules; Drug: Anlotinib Hydrochloride capsules; Drug: Irinotecan Hydrochloride for Injection

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yongsheng Li, Doctor; Phone Number: 18980602258; Email: wangys@wchscu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Recruiting
      • Chongqing University Cancer Hospital
      • Contact: Jianghong Wang, Master; Phone Number: 13983841209; Email: wjhwin16@163.com
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Recruiting
      • The First Hospital of Lanzhou University
      • Contact: Hongmei Yue, Master; Phone Number: 13893265368; Email: 13893289062@139.com
  • Guizhou
    • Guiyang, Guizhou, China, 550002
      • Recruiting
      • Guizhou Provincial People's Hospital
      • Contact: Yu Zhang, Doctor; Phone Number: 18885146684; Email: 248634489@qq.com
  • Shanxi
    • Xi'an, Shanxi, China, 710038
      • Recruiting
      • The Second Affiliated Hospital of PLA Air Force Military Medical University
  • Sichuan
    • Chengdou, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Yongsheng Li, Doctor; Phone Number: 18980602258; Email: wangys@wchscu.cn
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Cancer Hospital
      • Contact: Wenxiu Yao, Doctor; Phone Number: 18908178836; Email: ywxhlx@sina.com
  • Yunnan
    • Kunming, Yunnan, China, 650011
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Runxiang Yang, Doctor; Phone Number: 13888876721; Email: 13888876721@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects with pathologically proven small cell lung cancer(SCLC) or/and locally advanced ( Stage ⅢB/ ⅢC), metastatic or recurrent (Stage IV) non small cell lung cancer(NSCLC).
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:

1. Subjects who received prior therapy with anlotinib hydrochloride capsules.
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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: TQB3616 capsules; A CDK4/6 kinase inhibitor; Drug: Anlotinib Hydrochloride capsules; A multi-target receptor tyrosine kinase inhibitor
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.	Drug: TQB3616 capsules; A CDK4/6 kinase inhibitor; Drug: Irinotecan Hydrochloride for Injection; An inhibitor of DNA topoisomerase Ⅰ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate（DCR）	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 96 weeks
Progression-free survival (PFS)	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 96 weeks
Duration of Response (DOR)	The time when the participants first achieved CR or PR to disease progression or death from any cause.	up to 120 weeks
6-month progression-free survival rate	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 96 weeks
6-month and 12-month overall survival rate	OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.	up to 96 weeks

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2021
• Primary Completion (ANTICIPATED): May 23, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (ACTUAL): June 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: TQB3616-ALTN-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No