Anlotinib Plus Penpulimab in Advanced Non-Small-Cell Lung Cancer Previously Treated With PD-1/PD-L1 Inhibitors

NCT05460481 | Unknown Phase 2

• 1 other identifier: ALTER-L045
• Study Type: interventional
• Target: 29
• 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 # study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of advanced non-small-cell lung cancer (NSCLC) participants who have progressed following prior PD-1 or PD-L1 Inhibitors treatment, to further improve the patient's PFS or OS.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

  up to approximately 24 months

Secondary Outcomes (4)

• Progress free survival (PFS)

  up to approximately 24 months

• Overall Survival (OS)

  up to approximately 24 months

• Disease Control Rate (DCR)

  up to approximately 24 months

• Safety

  From the first assignment of informed consent form up to 21 days after the last dose

Study Arms (1)

Experimental: 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

Experimental: 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
• Non Small cell lung cancer pathologically confirmed, with measurable nidus (RECIST 1.1)
• Disease progression following prior Immune Checkpoint Inhibitors (PD-1 or PD-L1 inhibitors) treatment for NSCLC for at least 2 consecutive treatment cycles.
• EGFR/ALK/ROS1 wild type
• ECOG PS: 0-1, Expected Survival Time: Over 3 months
• Adequate bone marrow, liver and renal function
• 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:

• Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non small cell cancer)
• Have used Anlotinib or other antiangiogenic drugs before
• Known primary multidrug resistance to prior ICIs treatments
• Have failed for two times or beyond of platinum two drugs chemotherapy (except adjunctive chemotherapy, neoadjuvant therapy and concurrent chemoradiotherapy
• Iconography (CT or MRI) shows obvious lung empty or necrotic tumor iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor; Or 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≥ ++, and urine protein quantity≥ 1.0 g during 24 hours

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Henan Cancer Hospital: collaborator
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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 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: July 12, 2022
• First Posted: July 15, 2022
• Study Start: June 12, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07

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. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)