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

NCT05001971 | Completed Phase 2

• 1 other identifier: ALTER-L041
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  up to 24 months

Secondary Outcomes (4)

• PFS

  each 42 days up to PD or death (up to 24 months)

• OS

  From randomization until death (up to 24 months)

• DCR

  each 42 days up to intolerance the toxicity or PD or death (up to 24 months)

• Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability）

  Until 21 day safety follow-up visit

Study Arms (1)

Anlotinib Plus Penpulimab

EXPERIMENTAL

Anlotinib (10mg qd po d1-14, 21 days per cycle) and Penpulimab (200mg ivgtt d1)

Drug: Anlotinib Plus Penpulimab

Interventions

Anlotinib Plus Penpulimab DRUG

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.

Also known as: Anlotinib & Penpulimab

Anlotinib Plus Penpulimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• patients who had received chemotherapy, radiation, or other experimental anticancer therapy (except diphosphonate) within 4 weeks prior to the first dose of this study. Those who had previously received local radiotherapy were eligible if they met the following criteria: the end of radiotherapy was more than 4 weeks from the start of this study (brain radiotherapy was more than 2 weeks); In addition, the target lesions selected in this study were not in the radiotherapy area, or if the target lesion is within the radiotherapy area but progression has been confirmed
• 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)
• have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
• abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT ULN \> 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation
• have clinical significant hemoptysis occurred within 3 months before enrollment (daily hemoptysis more than half tablespoonl; Or clinical significant bleeding symptoms or bleeding tendency in the 4 weeks prior to grouping, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, but gastrointestinal perforation or fistula has been surgically removed, admission is allowed), baseline fecal occulted blood ++ or above, unhealed wounds, ulcers or fractures, etc
• urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
• uncontrollable hypertensive (SBP≥ 160 mmHg, DBP≥100 mmHg, despite the best drug treatment)

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator
• Hunan Cancer Hospital: lead
• Fuzhou Pulmonary Hospital of Fujian: collaborator

Study Sites (1)

Nong Yang

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib; penpulimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nong Yang, PhD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: August 12, 2021
• Study Start: January 30, 2021
• Primary Completion: January 21, 2025
• Study Completion: April 15, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement.

Locations

CN (1)