Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients

NCT04421352 | Completed Phase 1

• 1 other identifier: CS1001-101-13
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients

Conditions

Relapsed Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the recommended radiation dose and preliminarily evaluate the anti-tumor efficacy of CS1001 in combination with low-dose radiotherapy in subjects with limited or extensive stage SCLC who failed the firstline treatment

  From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

Secondary Outcomes (3)

• Incidence of Adverse Events (AE) and Dose-Limiting Toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03

  From first dose to 30 days after last dose of CS1001, up to 2 years.

• Cmax: Peak concentration, the maximum drug concentration measured during one dosing cycle

  From first dose to 30 days after last dose of CS1001, up to 2 years.

• The number and percentage of subjects with detectable Anti-drug Antibody (ADA)

  From first dose to 30 days after last dose of CS1001, up to 2 years.

Study Arms (1)

low-dose radiation+CS1001

EXPERIMENTAL

low-dose radiation+CS1001

Drug: CS1001

Interventions

CS1001 DRUG

low-dose radiation+CS1001 1200mg Q3W. In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. Dose A: 3Gy/1f; Dose B: 9Gy/3f; Dose C: 15Gy/5f; In the dose expansion part, more SCLC patients will be assigned.

low-dose radiation+CS1001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed LS-SCLC or ES-SCLC and experienced progression since first-line standard platinum containing dual-drug chemotherapy.
• Patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons
• At least one extracranial measurable lesion (RECIST v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed.
• Patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months.
• No radiotherapy contraindications were judged by the radiologist
• ECOG performance status of 0 or 1.
• Patients with life expectancy ≥ 3 months.
• Patients must have adequate organ function.
• Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 6 months after last study drug administration.

You may not qualify if:

• Subjects known to have primary CNS tumors or meningeal metastases or unstable CNS metastases.
• Patients with active autoimmune diseases or history of autoimmune diseases should be excluded.
• Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
• Known history of HIV infection.
• Subjects with active chronic hepatitis B or active hepatitis C .
• Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
• Known history of alcoholism or drugs abuse.
• Subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (5)

• Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

  PMID: 30280641 RESULT

• Ready N, Farago AF, de Braud F, Atmaca A, Hellmann MD, Schneider JG, Spigel DR, Moreno V, Chau I, Hann CL, Eder JP, Steele NL, Pieters A, Fairchild J, Antonia SJ. Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032. J Thorac Oncol. 2019 Feb;14(2):237-244. doi: 10.1016/j.jtho.2018.10.003. Epub 2018 Oct 10.

  PMID: 30316010 RESULT

• Li LY, Wang H, Chen X, Li WQ, Cui JW. First-line atezolizumab plus chemotherapy in treatment of extensive small cell lung cancer: a cost-effectiveness analysis from China. Chin Med J (Engl). 2019 Dec 5;132(23):2790-2794. doi: 10.1097/CM9.0000000000000536.

  PMID: 31856049 RESULT

• Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.

  PMID: 31590988 RESULT

• Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.

  PMID: 32417411 RESULT

MeSH Terms

Conditions

Small Cell Lung Carcinoma

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

• You Lu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 9, 2020
• Study Start: January 12, 2021
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)