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New drug cocktail shows promise in tough lung cancers

NCT ID NCT04924192

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called TQB3616 combined with either anlotinib or standard chemotherapy in 21 people with advanced lung cancer that had already been treated. The goal was to see if the combination could shrink tumors or slow the cancer's growth. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Aug 2021

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000, China

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000, China

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

    Xi’an, Shanxi, 710038, China

  • West China Hospital of Sichuan University

    Chengdou, Sichuan, 610041, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650011, China

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