Thoracic Consolidation Radiotherapy for ES-SCLC Treated With Chemo-immunotherapy

NCT06187740 | Unknown Phase 1

• 1 other identifier: ES-SCLC-TRT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to recruit ES-SCLC patients with response to standard first-line chemo-immunotherapy to assess the safety of receiving different doses of consolidative thoracic radiotherapy.

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

small cell lung cancer; chemotherapy; immunotherapy; thoracic radiotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related dose-limiting toxicities (DLTs)

  The proportion of the number of cases with DLTs associated with the study design treatment to the total evaluable number of cases was assessed according to CTCAE 5.0 criteria. Definition of dose-limiting toxicities (DLTs): Grade 3 or higher non-hematological/laboratory abnormalities reported events that may or definitely be associated with the combination of immunotherapy and thoracic consolidation radiotherapy as judged by the investigator, or Grade 4 or higher hematological/laboratory abnormalities reported.

  90 days after the start of thoracic consolidation radiotherapy in enrolled patients

Secondary Outcomes (1)

• Incidence of all dose limiting toxicities (DLTs):

  90 days after the start of thoracic consolidation radiotherapy in enrolled patients

Study Arms (3)

Starting Dose, Arm 1

EXPERIMENTAL

For ES-SCLC patients who completed first-line four-cycle chemo-immunotherapy, and was evaluated to have any response to treatment. Thoracic radiotherapy is administered to treat residual thoracic lesions during immunotherapy maintenance phase. Thoracic radiotherapy should begin within 42 days after the end of the last chemotherapy at an initial dose of 30 Gy in 10 fractions (3 patients).

Radiation: thoracic radiotherapy

Dose escalation 1, Arm 2

EXPERIMENTAL

Dose escalation will start after acceptable safety was observed, first at: 35 Gy/10 Fx (3 patients). Radiotherapy was administered between two immunotherapy doses (3 weeks interval) to avoid thoracic radiotherapy on the same day with immunotherapy. Immunotherapy was maintained until disease progression or the investigator 's judgment there was no further benefit from immunotherapy, patient died, intolerable toxicity developed. Toxicities were assessed periodically during the study. Local radiotherapy is permitted for symptomatic brain/bone metastases.

Radiation: thoracic radiotherapy

Dose escalation 2, Arm 3

EXPERIMENTAL

Dose escalation will continue after acceptable safety was observed in the previous dose gourp, at: 40 Gy/10 Fx (22 patients). Radiotherapy was administered between two immunotherapy doses (3 weeks interval) to avoid thoracic radiotherapy on the same day with immunotherapy. Immunotherapy was maintained until disease progression or the investigator 's judgment there was no further benefit from immunotherapy, patient died, intolerable toxicity developed. Toxicities were assessed periodically during the study. Local radiotherapy is permitted for symptomatic brain/bone metastases.

Radiation: thoracic radiotherapy

Interventions

thoracic radiotherapy RADIATION

Thoracic radiotherapy should begin within 42 days after the end of the last chemotherapy at an initial dose of 30 Gy in 10 fractions (3 patients). Dose escalation will start after acceptable safety was observed, first at: 35 Gy/10 Fx(3 patients), then to the next dose group: 40 Gy/10 Fx(22 patients). Radiotherapy was administered between two immunotherapy doses (3 weeks interval) to avoid thoracic radiotherapy on the same day with immunotherapy.

Dose escalation 1, Arm 2; Dose escalation 2, Arm 3; Starting Dose, Arm 1

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years;
• ECOG performance status score 0-2 points;
• pathologically confirmed small cell lung cancer;
• complete baseline imaging data (including brain enhanced MRI/CT, PET-CT or chest enhanced CT + bone scan + neck and abdominal B ultrasound/CT) before first-line treatment;
• stage extensive-stage SCLC at initial diagnosis, and first-line treatment received standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1) for at least 4 cycles after the efficacy assessment of SD or PR (residual lesions assessed by chest CT);
• no history of other malignancies;
• reproductive age male/female agreed to contraception during the trial (surgical ligation or oral contraceptives/intrauterine devices + condom contraception);
• life expectancy ≥ 3 months
• week before enrollment, the investigator judged that the patient could continue immune maintenance therapy at the same time, And the organ function level meets the following criteria:
• \) bone marrow function: hemoglobin ≥ 80 g/L, white blood cell count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L; 2) liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, when serum total bilirubin level \> 1.5 times the upper limit of normal direct bilirubin level must be ≤ the upper limit of normal,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times of the upper limit of normal; serum albumin ≥ 27 g/L; 3) Kidney: serum creatinine level \< 1.5 times of the upper limit of normal or creatinine clearance ≥ 50 ml/min, urea nitrogen ≤ 200 mg/L; 10.Patients must have the ability to understand and voluntarily sign an informed consent form.

You may not qualify if:

• baseline pathological examination found mixed with non-small cell lung cancer components;
• patients who had used any anti-tumor therapy before the diagnosis of ES-SCLC;
• patients who had received anti-tumor therapy other than standard chemotherapy + immunotherapy regimen;
• patients who had PD assessed by chemotherapy combined with immunotherapy efficacy;
• patients who had no residual thoracic lesions (lung, mediastinal and supraclavicular metastatic lymph nodes, thoracic efficacy CR) on chest enhanced CT during efficacy assessment;
• patients with severe immune-related toxicities after treatment;
• symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
• patients who required long-term use of cortisol or immunosuppressive agents;
• allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or other causes of inability to perform immune maintenance therapy;
• lactating or pregnant women;
• patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn 's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener' s granulomatosis), etc.;
• researchers believe that physical examination or clinical trials may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases;
• patients with mental illness, substance abuse, social problems affecting compliance are not enrolled after the doctor 's review.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

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

Central Study Contacts

Xiao Chu

CONTACT

15821383376; chuxiao@sibs.ac.cn

Huang Chen

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Department of Radiation Oncology

Model Details: Initial dose of 30 Gy in 10 fractions (3 patients, Arm 1). Dose escalation will start after acceptable safety was observed, 35 Gy/10Fx (3 patients, Arm 2), 40 Gy/10Fx (22 patients, Arm 3).

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 3, 2024
• Study Start: December 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)