Durvalumab With Chemotherapy Followed by Sequential Radiotherapy for Limited Stage Small Cell Lung Cancer

NCT05034133 | Unknown Phase 2 DMC

• 1 other identifier: BHHMEC-XM-2021-43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm Phase II study, in which 6 cycles of durvalumab with chemotherapy (Etoposide and Cisplatin) and durvalumab followed by Sequential radiotherapy for limited stage small cell lung cancer.

Conditions

Limited Stage Small Cell Lung Cancer

Keywords

Limited Stage Small Cell Lung Cancer; Durvalumab

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  The PFS time is defined as time from enrollment to locoregional or systemic

  Each 42 days up to intolerance the toxicity or PD (up to 24 months)

Secondary Outcomes (2)

• OS（Overall Survival）

  From enrollment until death (up to 24 months)

• Safety analysis

  1 year

Study Arms (1)

Study arm

EXPERIMENTAL

Patients with limited stage small cell lung cancer receive durvalumab with chemotherapy (Etoposide and Cisplatin) for receive 6 cycles, and then receive thoracic radiotherapy.

Drug: Durvalumab

Interventions

Durvalumab DRUG

Durvalumab (IV 1000mg on day 1) with chemotherapy (Etoposide and Cisplatin) for 6 cycles

Also known as: Etoposide and Cisplatin

Study arm

Eligibility Criteria

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

You may qualify if:

• Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Histologically confirmed small cell lung cancer
• Limited disease, defined as disease confined to one hemithorax, the mediastinum, and the bilateral supraclavicular fossae.
• Age \> 18 years at time of study entry
• ECOG performance status of 0 to 1
• Adequate normal organ and marrow function as defined below:
• Haemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC ≥ 1.5 (or 1.0) x (\> 1500 per mm3)
• Platelet count ≥ 100 (or 75) x 109/L (\>75,000 per mm3)
• Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN
• Serum creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and
• Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
• Males: Creatinine CL (mL/min) =Weight (kg) x (140 - Age)/ 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85/ 72 x serum creatinine (mg/dL)
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Patients with extensive disease small-cell lung cancer
• Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer
• Participation in another clinical study with an investigational product at any time
• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician

Sponsors & Collaborators

• Beijing Haidian Hospital: lead

Study Sites (1)

Beijing Haidian Hospital

Beijing, 100080, China

RECRUITING

MeSH Terms

Interventions

durvalumab; Etoposide; Cisplatin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Yuqing Huang, Director

  Beijing Haidian Hospital

  STUDY DIRECTOR

Central Study Contacts

Yuqing Huang, Director

CONTACT

+8601082693152; huangyuqing555@gmail.com

Xu Wang, Director

CONTACT

+8601062583013; hdyykj@sina.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: Director

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)