New drug cocktail shows promise in tough lung cancers
NCT ID NCT04924192
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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21 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Oct 2022
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
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Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
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Sichuan Cancer Hospital
Chengdu, Sichuan, China
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The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
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The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, 710038, China
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West China Hospital of Sichuan University
Chengdou, Sichuan, 610041, China
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Yunnan Cancer Hospital
Kunming, Yunnan, 650011, China
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Other studies related to the condition(s) this trial covers.
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