NCT07015892 Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial
| NCT ID | NCT07015892 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Instituto de Investigación Biomédica de Salamanca |
| Condition | Small Cell Lung Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2026-03-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase III clinical trial that aims to evaluate whether increasing the dose of radiotherapy given twice a day can improve treatment outcomes in patients with localized small cell lung cancer (SCLC). All patients will receive standard chemotherapy with cisplatin and etoposide and will be randomly assigned to one of three radiotherapy regimens. The main objective is to determine whether this intensified radiotherapy improves progression-free survival and overall survival. The study will also compare two different dose escalation strategies and assess treatment side effects and patients' quality of life. This research may help identify a more effective treatment approach for patients with limited-stage SCLC and could contribute to improving long-term survival in this aggressive type of cancer
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of small cell lung cancer (SCLC) * Limited-stage disease (Stage I-III; any T, any N, M0), eligible for definitive radiotherapy * Measurable disease according to RECIST 1.1 * Age ≥18 years * ECOG performance status 0-2 * No prior thoracic radiotherapy * Signed informed consent * Adequate hematologic function: WBC ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L * Adequate liver and renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤1.5×ULN, creatinine normal or CrCl ≥60 mL/min * Pulmonary function: FEV1 \>1 L or \>30% predicted; DLCO \>30% predicted Exclusion Criteria: * Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC) * Presence of malignant cells in pleural or pericardial effusion * Serious uncontrolled systemic disorders (e.g., active infection, unstable cardiovascular disease) * Medical, psychological, or social conditions that could interfere with compliance * Active malignancy other than SCLC (except localized prostate/breast cancer or basal cell carcinoma) * Refusal or inability to sign informed consent
Contact & Investigator
Iñigo San Miguel Arregui, MD PhD
PRINCIPAL INVESTIGATOR
Institute of Biomedical Research of Salamanca
Frequently Asked Questions
Who can join the NCT07015892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07015892 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07015892 currently recruiting?
Yes, NCT07015892 is actively recruiting participants. Contact the research team at isanm@saludcastillayleon.es for enrollment information.
Where is the NCT07015892 trial being conducted?
This trial is being conducted at Salamanca, Spain, Almería, Spain, Barakaldo, Spain, Girona, Spain and 9 additional locations.
Who is sponsoring the NCT07015892 clinical trial?
NCT07015892 is sponsored by Instituto de Investigación Biomédica de Salamanca. The principal investigator is Iñigo San Miguel Arregui, MD PhD at Institute of Biomedical Research of Salamanca. The trial plans to enroll 300 participants.