Anlotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer

NCT04660097 | Completed Phase 2 DMC

• 1 other identifier: HXNI-DA001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

Small Cell Lung cancer (SCLC) is a highly aggressive tumor that accounts for about 15 percent of all lung cancer cases. SCLC disease progresses rapidly, and about 2/3 of the patients have extensive stage (ES-SCLC) at the time of diagnosis, with extremely poor prognosis. However, the overall survival (OS) of ES-SCLC patients was not significantly prolonged, with platinum combined with etoposide chemotherapy as the standard treatment. In recent years, the emergence of Immune checkpoint inhibitor (ICI) has made the treatment of ES-SCLC appear at the dawn. In Impower133 study, Atezolizumab combined with chemotherapy significantly prolonged OS(median OS 12.3 months vs 10.3 months, HR=0.70, 95%CI 0.54-0.91, P = 0.007). Durvalumab combined with chemotherapy (CASPIAN study) is the first study in 20 years in which the total survival time of ES-SCLC treated by first-line therapy is 13 months, and there is no significant increase in adverse reactions compared with chemotherapy. Therefore, in 2019, NCCN also recommended Atezolizumab or Durvalumab+ EC regimens as a category 1 preferred option for first-line treatment of ES-SCLC.

Conditions

SCLC, Extensive Stage

Keywords

small cell lung cancer, Durvalumab

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  From date of the first dose of induction to date of objective disease progression or death, whichever came first,

  Assessed up to 60 months

Secondary Outcomes (8)

• Objective Response Rate (ORR )

  From the date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.

• Disease Control Rate (DCR)

  From the date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.

• overall survival (OS )

  From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months

• Time To Response (TTR)

  Up to 60 months

• Duration of response (DoR)

  Up to 60 month

Study Arms (1)

Outcome of Durvalumab-Etoposide-platinum in untreated ES-SCLC(CASPIAN trial)

OTHER

The outcome of CASPIAN

Drug: Anlotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer

Interventions

Anlotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer DRUG

This trial is single-armed IIb stage clinical trial to study the efficacy and safety of Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer . We use the outcome of CASPIAN trial as control group. The primary endpoint is ORR according to the RECIST 1.1, and secondary endpoints are PFS, OS, satety and life quality.

Also known as: Anlotinib Plus Durvalumab-Platinum-Etoposide Versus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer

Outcome of Durvalumab-Etoposide-platinum in untreated ES-SCLC(CASPIAN trial)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed primary treatment of ES-SCLC (small cell lung cancer) in male or female patients aged ≥18 and \<75 years.
• The ECOG energy status is 0 or 1.
• Appropriate hematologic and terminal organ functions.

You may not qualify if:

• Prior to systemic treatment, the patient had a history of chest radiation therapy or planned to undergo intensive chest radiation therapy.
• Spinal cord compression not explicitly treated by surgery and/or radiation, or previously diagnosed and treated, with no evidence of clinical stabilization of \>2 weeks prior to randomization. Active brain metastases (stable brain metastases may be admitted after treatment) occurred within one month prior to enrollment.
• Uncontrolled or symptomatic hypercalcemia, active tuberculosis, major cardiovascular disease.
• A history of autoimmune diseases, idiopathic pulmonary fibrosis, organized pneumonia, HIV positive, active hepatitis B, radiographic findings of tumor infiltration of the large vessels in the chest and significant pulmonary cavitation lesions, a previous history of hypertensive crisis or hypertensive encephalopathy.
• History of hemoptysis within 1 month prior to randomization (≥0.5 TSP of bright red blood per episode).
• Major surgery within 28 days or needle core biopsy or other minor surgical procedures within 7 days.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (2)

Sixth People's Hospital of Luoyang

Luoyang, Henan, 471000, China

Location

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib

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

• Yanqiu Zhao, MS

  Henan Tumor Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 9, 2020
• Study Start: May 20, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (2)