Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer

NCT04740021 | Unknown Phase 2

• 1 other identifier: LP002-II-SCLC-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 8

Brief Summary

LP002 is a highly selected recombinant humanized anti-PD-L1 monoclonal antibody. This is a single-arm, multicenter study to evaluate the efficacy and safety of LP002 in combination with chemotherapy in patients with extensive stage samll cell lung cancer.

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

  Up to approximately 15 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to approximately 15 months

• Disease Control Rate (DCR)

  up to approximately 15 months

• Duration of Response (DOR)

  up to approximately 15 months

• Number of Participants Who Experienced an Adverse Event (AE)

  up to approximately 15 months

Study Arms (1)

Experimental: LP002+EP

EXPERIMENTAL

Participants recieve LP002 10 mg/kg intravenous (IV) on day 1 PLUS carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on day 1 PLUS etoposide 100 mg/m\^2 IV on days 1, 2 and 3 of each 21-day cycle

Drug: LP002; Drug: Carboplatin; Drug: Etoposide

Interventions

LP002 DRUG

10 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.

Experimental: LP002+EP

Carboplatin DRUG

AUC 5 administered as IV infusion on Day 1 of each 21-day cycle.

Experimental: LP002+EP

Etoposide DRUG

100 mg/m\^2 administered as IV infusion on Day 1, 2 and 3 of each 21-day cycle.

Experimental: LP002+EP

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial;
• Age ≥ 18 and ≤ 79 years old, male or female;
• Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
• No prior systemic therapy for ES-SCLC.
• Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of extensive-stage SCLC.
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Has a life expectancy of ≥3 months.
• Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Has adequate organ function.
• Female participants of childbearing potential should have a negative pregnancy within 72 hours before the first dose of trial treatment. Male and female participants should agree to use an adequate method of contraception during the experiment and 24 weeks after the last administration of the test drugs.

You may not qualify if:

• Histologically or cytologically confirmed mixed SCLC.
• Suffered from other malignant tumors in the past 5 years (except skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have been effectively controlled).
• Prior to the first administration of the study drug, there was a grade \> 1 toxicity (excluding hair loss) caused by previous anti-tumor treatments.
• Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Uncontrolled or symptomatic hypercalcemia.
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≤ 1 week prior to the first dose of trial treatment.
• Has active autoimmune disease that has required systemic treatment in past 2 years.
• Has received a major surgery within 4 weeks prior to the first dose of trial treatment.
• Has received system treatment with corticosteroids (dose \>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
• Previous or present interstitial lung disease or non-communicable pneumonia, except for radiation pneumonia.
• Has uncontrolled systemic disease, such as diabetes or hypertension.
• Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
• Has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV). Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA \< 10\^3 copies/ml or \<500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.

Sponsors & Collaborators

• Taizhou HoudeAoke Biomedical Co., Ltd.: lead

Study Sites (8)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

NOT YET RECRUITING

Affiliated Hospital Of Jiangnan University

Wuxi, Jiangsu, 214122, China

RECRUITING

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Xinjiang Medical University Cancer Center

Ürümqi, Xinjiang, 830011, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Jialei Wang

CONTACT

021-64175590; wangjialeigcp@126.com

Study Design

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

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: December 2, 2020
• Primary Completion: February 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

CN (8)