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

NCT04924192 | Terminated Phase 2

• 1 other identifier: TQB3616-ALTN-II-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Advanced Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Percentage of participants achieving complete response (CR) and partial response (PR).

  up to 96 weeks

Secondary Outcomes (5)

• Progression-free survival (PFS)

  up to 96 weeks

• Disease control rate（DCR）

  up to 96 weeks

• Duration of Response (DOR)

  up to 120 weeks

• 6-month progression-free survival rate

  up to 96 weeks

• 6-month and 12-month overall survival rate

  up to 96 weeks

Study Arms (2)

TQB3616 capsules+Anlotinib hydrochloride capsules

EXPERIMENTAL

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; Drug: Anlotinib Hydrochloride capsules

TQB3616 capsules +Irinotecan Hydrochloride for Injection

EXPERIMENTAL

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; Drug: Irinotecan Hydrochloride for Injection

Interventions

TQB3616 capsules DRUG

A CDK4/6 kinase inhibitor

TQB3616 capsules +Irinotecan Hydrochloride for Injection; TQB3616 capsules+Anlotinib hydrochloride capsules

Anlotinib Hydrochloride capsules DRUG

A multi-target receptor tyrosine kinase inhibitor

TQB3616 capsules+Anlotinib hydrochloride capsules

Irinotecan Hydrochloride for Injection DRUG

An inhibitor of DNA topoisomerase Ⅰ

TQB3616 capsules +Irinotecan Hydrochloride for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (7)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

The Second Affiliated Hospital of PLA Air Force Military Medical University

Xi’an, Shanxi, 710038, China

Location

West China Hospital of Sichuan University

Chengdou, Sichuan, 610041, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650011, China

Location

MeSH Terms

Interventions

Irinotecan; Injections

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 11, 2021
• Study Start: August 18, 2021
• Primary Completion: September 27, 2022
• Study Completion: October 10, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (7)