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

Advanced Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924192
• Other study ID #: TQB3616-ALTN-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 18, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yongsheng Li, Doctor
• Phone: 18980602258
• Email: wangys[@]wchscu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 30, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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).

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. -

Related Conditions & MeSH terms

• Advanced Lung Carcinoma
• Lung Neoplasms

Intervention

Drug:
• 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 ?

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdou	Sichuan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Second Affiliated Hospital of PLA Air Force Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 96 weeks
Secondary	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
Secondary	Disease control rate(DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 96 weeks
Secondary	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
Secondary	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
Secondary	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