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Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy

Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy: a Single-arm, Multicenter Pilot Study

NCT05001971•Hunan Cancer Hospital

View on ClinicalTrials.gov

Summary

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase II ALTER1202 trial, patients who failed at least two kinds of systemic chemotherapy regimens (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 4.1 months and 7.3 months, the placebo group PFS and OS were 0.7 months and 4.9 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of sensitive relapsed small-cell lung cancer patients who were failure in the first-line treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS.

Detailed Description

This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the effectiveness and safety of Anlotinib Plus Penpulimab in patients with small cell lung cancer after failure of platinum-based chemotherapy. Eligible patients will receive Anlotinib plus Penpulimab: Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•signed and dated informed consent
•Small cell lung cancer pathologically confirmed, with measurable nidus (RECIST 1.1)
•have failed for first-line chemotherapy
•have a time interval ≥ 3 months between relapse and the end of the last systemic chemotherapy
•ECOG PS: 0-1, Expected Survival Time: Over 3 months
•main organs function is normal
•the woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 8 weeks after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.
•other kinds of malignancies within 5 years or for now
•patients who have an active, known or suspected autoimmune disease, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, a history of being HIV positive, or a history of acquired immunodeficiency syndrome (AIDS)
•active or previously recorded inflammatory bowel disease (such as Crohn's disease, ulcerative colitis)
+15 more criteria

Exclusion Criteria

•have used Anlotinib or other antiangiogenic drugs before
•have used Penpulimab or other anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, as well as any other antibodies or drugs targeting T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.)
•have failed for two times or beyond of platinum two drugs chemotherapy (except adjunctive chemotherapy, after which disease relapse or progression within 6 months，has been regarded as first-line therapy.)
•iconography (CT or MRI) shows obvious lung empty or necrotic tumor
•patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (28 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage)
•patients are participating in other clinical studies (other than non-interventional studies) less than 4 weeks from the end of the previous clinical study

Locations (1)

Nong Yang

Changsha, Hunan, China

Key Dates

Start Date

January 30, 2021

Primary Completion Date

January 21, 2025

Completion Date

April 15, 2025

Last Updated

January 15, 2026

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer

Interventions

Anlotinib Plus Penpulimab

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

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Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy