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RECRUITINGPHASE1/PHASE2

Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC

Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer

NCT06217757•Sichuan University

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.

Detailed Description

This study consists of dose escalation and dose expansion in China. Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with Sugemalimab, Etoposide/Cisplatin Chemotherapy and Olaparib for 4 cycles with LDRT in the first cycle. Sugemalimab in combination with olaparib will be administered for maintenance therapy after 4 cycles. Sugemalimab will be administered at a dose of 1200 mg every 3 weeks (Q3W) in the first day of every cycle. The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from day 1 in the first cycle. Dose of olaparib will identify by assessed recommended dose for expansion (RDE) in dose escalation stage.A dose expansion stage will be conducted after dose escalation. The primary endpoint is safety.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women aged more than or equal to (≥) 18 years old and less than or equal to (≤) 75 years old
•2. Histologically or cytologically confirmed ES-SCLC
•3. No prior treatment for ES-SCLC
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•5. Five white slides (unstained paraffin sections) were available for immunohistochemical SLFN-11 detection and SLFN-11 was positive
•6. Extensive clinical stage. American Joint Committee on Cancer (AJCC) 8th edition Stage IV with lesions exceeding one side of the chest and including malignant pleural and pericardial effusions or hematogenous metastases (any T, any N, M1a/b/c); or T3-4 due to multiple nodules in the lung or tumor/nodule size too large to be included in a T3-4 disease within a tolerable radiotherapy schedule
•7. The subjects were considered suitable for combining etoposide with cisplatin chemotherapy and low-dose radiotherapy as first-line treatment for extensive -stage small cell lung cancer
•8. Have measurable lesions as defined by RECIST1.1, with at least one lesion (never previously treated with radiation) of ≥10 mm longest diameter accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must have a short axis of ≥15 mm) and the lesion is suitable for repeat and accurate measurements
•9. Patients with brain metastases must be asymptomatic or stable on steroids and anticonvulsants for at least 1 month prior to study treatment. Participants with suspected brain metastases during screening should have a CT/MRI of the brain prior to study
•10. No previous treatment with immune checkpoint inhibitors and PARP inhibitors, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, with the exception of therapeutic anti-tumor vaccines. No prior chemotherapy or radiation therapy to the chest lesion
+5 more criteria

Exclusion Criteria

•1. Histopathologic or cytopathologic diagnosis of mixed small cell lung cancer or non-small cell lung cancer
•2. Limited stage small cell lung cancer
•3. Combination of poorly controlled malignant pleural or pericardial effusions requiring continuous drainage
•4. Presence of active or symptomatic brain metastases or Leptomeningeal metastases
•5. Prior systemic antitumor therapy (chemotherapy, targeted agents such as PARP inhibitors) or immune checkpoint inhibitors for SCLC
•6. Presence of active, unstable systemic disease such as active infection, autoimmune disease, inflammatory disease (uncontrolled hypertension, heart failure (NYHA classification \>= Class II), unstable angina, acute coronary syndrome, severe arrhythmia, severe hepatic, renal or metabolic disease, human immunodeficiency virus (HIV) immunodeficiency virus (HIV) infected patients
•7. Previous allogeneic stem cell or solid organ transplantation
•8. Patients with prior interstitial lung disease, drug-induced interstitial lung disease, or active interstitial pneumonia requiring systemic glucocorticoid or immunosuppressive therapy; Patients with pulmonary interstitial fibrosis or active pulmonary tuberculosis
•9. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia
•10. Received therapeutic oral or intravenous infusion of antibiotics within 2 weeks prior to the start of study treatment
+8 more criteria

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

April 18, 2024

Primary Completion Date

June 20, 2026

Completion Date

March 20, 2027

Last Updated

May 13, 2024

Enrollment

ESTIMATED participants

Conditions

Lung CancerExtensive-stage Small-cell Lung Cancer

Interventions

Low-dose radiotherapy

RADIATION

Etoposide

DRUG

Cisplatin

DRUG

Sugemalimab

DRUG

Olaparib

DRUG

Contacts

Min Yu, MD

CONTACT

02885423571 yuminisagoodgirl@163.com

You Lu, MD

CONTACT

02885423571 radyoulu@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC

Inclusion Criteria

Exclusion Criteria

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