Durvalumab Plus Etoposide-free Chemotherapy in First-line Treatment of Extensive-disease Small-se… (NCT05856695) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Durvalumab Plus Etoposide-free Chemotherapy in First-line Treatment of Extensive-disease Small-sell Lung Cancer (SCLC)
France67 participantsStarted 2023-11-17
Plain-language summary
The current study is intended to be a "proof of concept" to evaluate the potential value of synergy between paclitaxel carboplatin and immunotherapy. If a signal clearly shows superiority over the CASPIAN data , we will have arguments to think that the combination of paclitaxel and carboplatin is more suitable for synergy with immunotherapy than the standard etoposide and carboplatin.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed consent.
. Patients diagnosed with histologically confirmed SCLC
. Extended-Stage Disease at time of accrual according to the criteria of the Veteran's Administration Lung Cancer Group (VALG). Extended disease is defined as going beyond hemithorax and supraclavicular ganglionic areas, and malignant pleural effusions will be considered extended diseases.
. At least one measurable target lesion according to RECIST v1.1 per investigator assessment.The radiological assessment has to be done within the timelines indicated.
. Age ≥ 18 years.
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see Appendix 1).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: At 12 months
Trial details
NCT IDNCT05856695
SponsorIntergroupe Francophone de Cancerologie Thoracique
. Non-small cell lung cancer (NSCLC) or combined SCLC and NSCLC.
. Prior systemic anticancer therapy for SCLC.
. Radiotherapy needed at initiation of treatment.
. Major surgical procedure (as defined by the Investigator) within 28 days prior initiation of treatment.
. Symptomatic brain metastasis. Note: patient with asymptomatic or treated and stable brain metastasis for at least 1 month prior to study treatment are eligible. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.