Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC

NCT04055792 | Completed Phase 2 DMC

• 1 other identifier: 20200526
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Small cell lung cancer (SCLC) accounts for 10-15% of lung cancer. More than 70% of SCLC patients are diagnosed with advanced stage (ED-SCLC) at diagnosis. ED-SCLC is highly chemo-sensitive, the first-line treatment is platinum-containing double-drug chemotherapy. Although ED-SCLC is highly sensitive to chemotherapy and the objective response rate (ORR) of first-line chemotherapy is as high as 60-80%, the progression-free survival (PFS) is very short, and there is a lack of effective second-line treatment. The median overall survival (OS) of patients is only 10 months, and the 2-year survival rate is about 6%.

Conditions

Extensive Disease Small Cell Lung Cancer

Keywords

extensive disease small cell lung cancer; PD-1 inhibitor; anti-angiogenesis; second or further-line setting

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  8 months

Secondary Outcomes (3)

• OS

  24 months

• ORR

  8 months

• DCR

  8 months

Study Arms (1)

Sintilimab combine with Anlotinib

EXPERIMENTAL

Sintilimab 200 mg on day 1 and oral daily Anlotinib 12 mg on days 1-14 once every 3 weeks

Drug: Sintilimab

Interventions

Sintilimab DRUG

Sintilimab 200mg intravenously on day 1 and Anlotinib 12 mg on days 1-14 once every 3 weeks

Also known as: Anlotinib

Sintilimab combine with Anlotinib

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following criteria to be enrolled:
• Histologically or cytologically confirmed ED-SCLC according to the VALG staging system, and not suitable for local treatment.
• Progressed after at least one line of platinum-containing chemotherapy.
• ≥1 measurable lesions based on Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1).
• Previous radiotherapy was allowed, but the radiotherapy area must be \<25% of the bone marrow area (Cristy and Eckerman 1987) and no total pelvic or chest irradiation was used; the previous radiotherapy must have been completed for at least 4 weeks before the start of study drugs treatment, and the acute toxicity must have been restored; radiotherapy of local lesions cannot be included in measurable lesions unless significant progression is noted after radiotherapy.
• Prior surgery was allowed, provided that the treatment was completed at least 4 weeks before the start of study drugs treatment, and the acute toxicity must have been restored.
• ≥18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
• Life expectancy \> 12 weeks.
• Adequate bone marrow, hepatic and renal function.
• Systolic blood pressure ≤160mmHg and diastolic pressure ≤90mmHg within 7 days before enrollment.
• Patients must sign study specific informed consent before registration.
• Female patients should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactating; Male patients should be surgically sterilized or who have consented to use a medically approved form of contraception during the study treatment period and for 6 months after the end of the study treatment period.

You may not qualify if:

• Any of the following conditions should not be included in this study:
• Patients with brain metastasis. Patients suspected of having brain metastases should be examined by brain CT or MRI before enrollment; Patients with a history of brain metastases must have completed treatment and no longer need corticosteroids; For asymptomatic patients, the investigator will determine whether to enroll.
• Patients with meningeal metastasis.
• Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or anti-angiogenic treatment.
• Accept any other anti-tumor treatment simultaneously.
• Diagnosed with active autoimmune diseases (congenital or acquired, patients with completely relieved or childhood vitiligo can be enrolled; patients with hypothyroidism and only need hormone replacement therapy can be rerolled; Patients with type 1 diabetes can also be enrolled).
• Diagnosed with interstitial pneumonia.
• Patients with hemorrhage tendency including acute hemorrhage of digestive tract, continuous hemorrhage disease or coagulation function disorder disease.
• Patients are using warfarin, heparin or aspirin (\>325 mg/day) or NSAIDS to inhibit platelet function within 10 days prior to enrollment, or receiving dipyridamole, ticlopidine, clopidogrel or cilostazol treatment.
• Patients with accompanying diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
• Pregnant or lactating female.
• Prior other malignant diseases, except for cervical carcinoma in situ, papillary thyroid carcinoma, or non-melanoma skin cancer.
• Allergy to any component of the study drugs.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• Ma S, He Z, Liu Y, Wang L, Yang S, Wu Y, Chen H, Wu Y, Wang Q. Sintilimab plus anlotinib as second or further-line therapy for extensive disease small cell lung cancer: a phase 2 investigator-initiated non-randomized controlled trial. EClinicalMedicine. 2024 Mar 14;70:102543. doi: 10.1016/j.eclinm.2024.102543. eCollection 2024 Apr.

  PMID: 38516099 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

sintilimab; anlotinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiming Wang

  127 Dongming Road, Zhengzhou, 450008, People's Republic of China

  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: chief physician

Model Details: A prospective, single-arm, Phase II study

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 14, 2019
• Study Start: September 11, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)