AzTrials
AzTrials

Advanced Lung CarcinomaPhase 2NCT04924192

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

A Phase 2 study testing TQB3616 capsules, Anlotinib Hydrochloride capsules and Irinotecan Hydrochloride for Injection in people with Advanced Lung Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Lung Carcinoma
What is being tested?
TQB3616 capsules, Anlotinib Hydrochloride capsules and Irinotecan Hydrochloride for Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
7 sitesChina
Study dates
18 Aug 2021to 10 Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • -

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • West China Hospital of Sichuan University

    Chengdou, Sichuan, 610041

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650011

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The Second Affiliated Hospital of PLA Air Force Military Medical University

    Xi’an, Shanxi, 710038

Other trials in China

About this study

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.

Being tested
TQB3616 capsules, Anlotinib Hydrochloride capsules, Irinotecan Hydrochloride for Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3616 capsulesDrug

    A CDK4/6 kinase inhibitor

  • Anlotinib Hydrochloride capsulesDrug

    A multi-target receptor tyrosine kinase inhibitor

  • Irinotecan Hydrochloride for InjectionDrug

    An inhibitor of DNA topoisomerase Ⅰ

Study groups in NCT04924192
Study groupRoleWhat they receive
TQB3616 capsules+Anlotinib hydrochloride capsulesExperimentalTQB3616 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.
Receives: Drug: TQB3616 capsules; Drug: Anlotinib Hydrochloride capsules
TQB3616 capsules +Irinotecan Hydrochloride for InjectionExperimentalTQB3616 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.
Receives: Drug: TQB3616 capsules; Drug: Irinotecan Hydrochloride for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

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

    Measured: up to 96 weeks

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

    Measured: up to 96 weeks

  2. Disease control rate（DCR）

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

    Measured: up to 96 weeks

  3. Duration of Response (DOR)

    The time when the participants first achieved CR or PR to disease progression or death from any cause.

    Measured: up to 120 weeks

  4. 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.

    Measured: up to 96 weeks

  5. 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.

    Measured: up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start18 Aug 2021
  3. Primary completion27 Sep 2022
  4. Study completion10 Oct 2022

Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04924192
Sponsor's protocol ID
TQB3616-ALTN-II-01
Status last verified
Apr 2026
First submitted
10 Jun 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB3616 capsules, Anlotinib Hydrochloride capsules and Irinotecan Hydrochloride for Injection in people with Advanced Lung Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: up to 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in