Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

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

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

Sintilimab

Qiming Wang

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%.

In August 2018, the FDA approved Nivolumab as a third-line treatment for ED-SCLC patients. Sintilimab is another PD-1 inhibitor produced by China and has been approved by cFDA for lymphoma. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) with effect of anti-tumor angiogenesis and tumor growth inhibition. The results of ALTER1202 showed that compared with placebo, Anlotinib single-agent as third-line treatment in ED-SCLC was effective, the median PFS was 4.1 versus 0.7 months, respectively (P \< 0.001).

Immunotherapy combined with anti-angiogenic therapy has been proven effective and tolerable in non-small cell lung caner (NSCLC), while its efficacy and safety in SCLC has not been reported. Therefore, the investigators conduct this study to evaluate the efficacy and safety of Sintilimab combined with Anlotinib as second or further-line therapy for ED-SCLC patients.

A prospective, single-arm, Phase II study

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

Sintilimab Combined With Anlotinib as Second- or Further-line Therapy for Extensive Disease Small Cell Lung Cancer: A Prospective, Single-arm, Phase II Study

Henan Cancer Hospital

chief physician

Symptoms and General Pathology

Recurrence

Carcinoma, Non-Small-Cell Lung

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care

Patients with extensive disease small cell lung cancer who are planning to provide atezolizumab combination therapy as the most appropriate medical care

Akihiko GENMA

This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.

The biomarkers which enable to select the appropriate patient in atezolizumab combination therapy are exploratory examined with the 3 methods below.

* Analysis of PD-L1 SNPs
* Comprehensive analysis of plasma protein expression
* Analysis of the immune microenvironment of small cell lung cancer

The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

The Exploratory Study to Evaluate Biomarkers in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer (J-TAIL-2)

All IPD that underlie results in a publication.

Japan Lung Cancer Society

Chugai Pharmaceutical

Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care

Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care

This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)

Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer

All IPD that underlie results in a publication

Percentage of participants alive 12 months after initiation of treatment

OS was defined as the time from the first day of study treatment to death due to any cause

Percentage of participants alive 6 months after initiation of treatment

Percentage of participants alive 18 months after initiation of treatment

PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)

TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death

Rate of patients who received drug therapy for primary disease after study treatment

Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1

Duration of Response as Assessed by the Investigator According to RECIST v1.1

Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1

The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0

The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib 400mg, bid(800mg/day), daily, PO

JI-YOUN HAN, PhD.MD

A Phase I trial of weekly topotecan in combination with sorafenib in treatment of relapsed Small cell lung cancer (SCLC) has been commenced. In the present randomized phase 2 study, the investigators will research whether Sorafenib maintenance prolongs progression free survival (PFS) and overall survival (OS) in patients with ED-SCLC who achieved CR or PR after platinum-based induction chemotherapy.

Small cell lung cancer (SCLC) comprises 10-15 % of all lung cancer. Despite high responsiveness to initial chemotherapy, its high relapse rate makes the treatment of SCLC is challenging. With platinum plus etoposide or irinotecan, overall response rate is as high as 85%, however, the median duration of response is short (approximately 4 months), and median survival times are 9 to 11 months, with a 2-year survival rate of less than 10% \[J Clin oncology. 2009 Oct 1;27(28):4787-92\]. New and more effective agents are clearly needed against SCLC. Sorafenib is a multikinase inhibitors acting on pathways involved in tumour progression and angiogenesis, and is undergoing investigation for the treatment of SCLC in either the first- or second-line setting. The only data available so far are on sorafenib, which seems to be a promising agent with a median survival of 7 and 5 months in platinum-sensitive and platinum-refractory patients, respectively (2008 J Clin oncology 26. Abstract 8039). This compared favourably with historical controls receiving salvage chemotherapy.

Study of Sorafenib Maintenance in Patients With ED-SCLC After Response to Induction Chemotherapy

A Randomized Phase II Study of Sorafenib Maintenance in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC) After Response to Induction Chemotherapy

Progression-free survival was calculated from the randomization date until evidence of PD or death

The duration of overall survival is measured from randomization date to the date of death from any cause or the last follow-up examination

For grading of adverse events CTCAE criteria (version 4.0) will be utilized. All adverse events occurring between first drug intake until 30 days after last treatment administration will be reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC	NCT04055792	Extensive Disea...	Sintilimab	18 Years -	Henan Cancer Hospital
The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)	NCT04818983	Non-small Cell ... Extensive Disea...		20 Years -	Chugai Pharmaceutical
Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)	NCT04501497	Non-small Cell ... Extensive Disea...		20 Years -	Chugai Pharmaceutical
Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC	NCT04055792	Extensive Disea...	Sintilimab	18 Years -	Henan Cancer Hospital
Study of Sorafenib Maintenance in Patients With ED-SCLC After Response to Induction Chemotherapy	NCT01159327	Small Cell Lung...	Sorafenib	18 Months -	National Cancer Center, Korea

Spots Global Cancer Trial Database for extensive disease small cell lung cancer