First-line Chemotherapy Followed by Toripalimab Combined With Anlotinib for Maintenance in ES-SCLC

NCT04363255 | Unknown Phase 2

• 1 other identifier: LDQ-202004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Our aim in this study was to evaluate the efficacy and safety of etoposide combined with cisplatin or carboplatin (EC/EP) chemotherapy regimens followed by toripalimab combined with anlotinib for maintenance in extensive small cell lung cancer(ES-SCLC).

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  PFS

  Duration of time from the start of chemotherapy to the time of disease progression, assessed up to 3 years

• Overall survival (OS)

  OS

  Duration of time from the start of chemotherapy to the time of outcome events, assessed up to 3 years

Secondary Outcomes (4)

• Adverse event (AE)

  Duration of time from the start of treatment to the end of study, assessed up to 3 years

• Objective response rate (ORR)

  Duration of time from the start of treatment to the end of study, assessed up to 3 years

• Disease control rate (DCR)

  Duration of time from the start of treatment to the end of study, assessed up to 3 years

• Duration of response (DoR)

  Duration of time from the start of treatment response to the time of disease progression, assessed up to 3 years

Study Arms (1)

Maintenance group

EXPERIMENTAL

After 4-6 cycles of EP/EC chemotherapy regiment, maintenance therapy with toripalimab and anlotinib was followed and continued until disease progression.

Drug: Etoposide Injection; Drug: Carboplatin Injection; Drug: Cisplatin injection; Drug: Toripalimab; Drug: Anlotinib hydrochloride

Interventions

Etoposide Injection DRUG

Etoposide(100mg/m2, d1-3, q3w) combined with platinum was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.

Also known as: Etoposide

Maintenance group

Carboplatin Injection DRUG

Carboplatin(AUC 5, d1, q3w) or Cisplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.

Also known as: Carboplatin

Maintenance group

Cisplatin injection DRUG

Cisplatin(75mg/m2, d1, q3w) or carboplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.

Also known as: Cisplatin

Maintenance group

Toripalimab DRUG

After 4-6 cycles of chemotherapy, JS001(240mg, d1, q3w) combined with anlotinib were followed and continued until disease progression.

Also known as: JS001

Maintenance group

Anlotinib hydrochloride DRUG

After 4-6 cycles of chemotherapy, anlotinib(12mg qd, d1-14, q3w) combined with JS001 were followed and continued until disease progression.

Also known as: Anlotinib

Maintenance group

Eligibility Criteria

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

You may qualify if:

• \. Patients must sign a specific informed consent form prior to clinical trial; 2. Extensive stage small cell lung cancer confirmed by histology or cytology; 3. Patients did not receive any system treatment before or only received EP/EC chemotherapy (time from the last medication of chemotherapy to the beginning of maintenance treatment must be ≤21 days); 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5. An estimated survival duration of \>5 months from the beginning of chemotherapy; 6. Age no less than 18; 7. A measurable lesion on image; 8. Patients with asymptomatic brain metastases or symptomatic brain metastases which were stable after treatment; 9. Before the first dose of drugs for study, patients should have appropriate organ function and the laboratory results must meet conditions as following: Blood routine examination: neutrophil absolute value (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin content (HGB) ≥9g/dl; Adequate hepatic function: bilirubin ≤1.5×ULN mg/dl, creatinine clearance ≥ 50 ml/min; Adequate hepatic function: Aspartate aminotransferase (AST) /alanine aminotransferase (ALT)\> 2.5 × upper limit of normal (ULN) or \> 5 × ULN (patients with liver metastasis), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (patients with bone metastasis), Total bilirubin (TB) ≤1.5×ULN, albumin (ALB)\>30g/dl; Coagulation function: international normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN; Urine routine: 24-hour urine protein\<1g (if urine protein ≥2+, additional 24-hour urine protein is required); Others: serum lipase or amylase ≤1.5×ULN or \>1.5×ULN (subjects clinically or radiologically diagnosed with pancreatitis).

You may not qualify if:

• \. Patients received EP/EC regiment received the last medication ≥21 days before maintenance treatment, or received other systematic anti-tumor treatment for ES-SCLC; 2. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation; 3. Patients received any other experimental drugs or participated in another interventional clinical study within 4 weeks prior to signing the informed consent; 4. Patients received other systemic or local antitumor therapy (including but not limited to the use of other drugs for SCLC maintenance therapy or radiotherapy, but CR/PR subjects are allowed to use prophylactic cranial irradiation (PCI) after induction period treatment); 5. Patients with active and untreated brain metastases or carcinoma meningitis in CT or MRI examination during screening stage; 6. Patients with other malignant tumors within 5 years, except for curable malignant tumors (carcinoma in situ or stage I tumor), such as cervical carcinoma in situ, basal cell or squamous cell skin cancer and so on); 7. Patients received corticosteroids (\>10mg/ day methyl prednisolone or equivalent dose) or other immunosuppressants (inhalation or local use of steroids and adrenal replacement treatment were permitted in the absence of an active autoimmune disease) less than 14 days prior to maintenance medications; 8. Patients with chronic or acute active hepatitis B (HBsAg positive and hepatitis B virus (HBV) DNA copy number \>ULN), or HCV positive (HCV Ab positive and HCV RNA positive); Hepatitis B patients with previous HBV infection or who have been cured (HBsAg negative, HBcAb positive and HBV DNA copy number \< ULN) were allowed to be enrolled; 9. Patients with interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or active pneumonia with clinical symptoms; or other lung diseases causing moderate or severe lung dysfunction; Active pulmonary tuberculosis or the need for anti-tuberculosis treatment; 10. Patients who were allergy to one of research drugs, or allergy to any one of the immunocheckpoint inhibitors or other platinum; 11. Female patients during pregnant and lactation period, or patients were plan to pregnant; 12. Patients with factors that may cause the study to be forced to terminate halfway according to investigators' judgement, such as poor compliance, other serious diseases requiring combined treatment and so on.

Sponsors & Collaborators

• Taizhou Hospital: lead

Study Sites (2)

Enze Hospital, affiliated Taizhou Hospital of Wenzhou Medical University

Taizhou, Zhejiang, China

Location

Haihua, Yang

Taizhou, Zhejiang, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Etoposide; Carboplatin; Cisplatin; toripalimab; anlotinib

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)

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

Study Officials

• Dongqing Lv, MD

  Enze Hospital affiliated Taizhou hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongqing Lv, MD

CONTACT

13867622009; lvdq@enzemed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The head of radiotherapy department in Taizhou Hospital

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: May 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)