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

ConditionsLung CancerExtensive-stage Small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women aged more than or equal to (≥) 18 years old and less than or equal to (≤) 75 years old

Histologically or cytologically confirmed ES-SCLC

No prior treatment for ES-SCLC

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Disqualifiers

Histopathologic or cytopathologic diagnosis of mixed small cell lung cancer or non-small cell lung cancer

Limited stage small cell lung cancer

Combination of poorly controlled malignant pleural or pericardial effusions requiring continuous drainage

Presence of active or symptomatic brain metastases or Leptomeningeal metastases

Trial design

Design model

Single group

Treatments tested in this trial

  • Low-dose radiotherapy

    Radiation

    The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.

  • Etoposide

    Drug

    Etoposide will be administered intravenously at a dose of 100 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

  • Cisplatin

    Drug

    Cisplatin will be administered as intravenous infusion at a dose of 25 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

  • Sugemalimab

    Drug

    Sugemalimab will be administered by intravenous infusion at a dose of 1200mg on Day 1 of each 21-day cycle for a maximum of 2 years or progressive disease or intolerable toxicity.

  • Olaparib

    Drug

    Olaparib will be administered orally at a dose of 150mg qod Day 1,3,5,7 or 150 mg qd/150 mg bid/300mg in the morning and 150mg in the evening/300 mg bid on Day 1-7 of each 21-day cycle for a maximum of 2 years or progressive disease or intolerable toxicity.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Low-dose radiotherapy combined with sugemalimab, olaparib, etoposide and cisplatinExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

RDE

To determine the RDE of olaparib in subjects with Extensive Stage-SCLC when combined with low-Dose Radiotherapy, chemotherapy and sugemalimab.

Time frame
3 weeks after initiation of treatment.

Secondary outcomes

1

Progression-free survival (PFS)

The time from the date of first dosing of sugemalimab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

Time frame
Baseline up to approximately 24 months
2

PFS Rate at 6 Months and 1 Year

PFS rate at 6 months and 1 year, defined as the proportion of patients who have not experienced disease progression or death from any cause at 6 months and 1 year separately, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST1.1).

Time frame
Baseline up to 1 year
3

Overall Survival (OS)

OS, defined as the time from initiation of study treatment to death from any cause.

Time frame
Baseline up to approximately 24 months
4

OS Rate at 1 Year, 1.5 Years and 2 Years

OS rate at 1 year, 1.5 years and 2 years, defined as the proportion of patients who have not experienced death from any cause at 1 year ,1.5 years and 2 years.

Time frame
Baseline to 2 years or death, whichever occurs first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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