- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07822984
Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant NSCLC After First-Line Third-Generation EGFR-TKI Plus Chemotherapy
10 september 2026 uppdaterad av: Zhengfei Zhu, Fudan University
Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant Non-Small Cell Lung Cancer After First-Line Treatment With Third-Generation EGFR Tyrosine Kinase Inhibitor Plus Chemotherapy: A National Multicenter, Randomized Controlled Clinical Trial
This national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus platinum-based pemetrexed chemotherapy.
Eligible participants will be randomized 1:1 to continue third-generation EGFR-TKI plus pemetrexed maintenance therapy alone or to receive stereotactic radiotherapy to all oligo-residual lesions in addition to the same maintenance therapy.
The primary endpoint is progression-free survival.
Studieöversikt
Status
Har inte rekryterat ännu
Studietyp
Interventionell
Inskrivning (Beräknad)
374
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer.
- Clinical stage IV disease according to the AJCC 9th edition.
- Sensitizing EGFR mutation: EGFR exon 19 deletion or EGFR L858R.
- Age 18-75 years.
- Karnofsky Performance Status score ≥70.
- Complete whole-body imaging assessment before initiation of first-line third-generation EGFR-TKI plus chemotherapy, with at least one evaluable lesion according to RECIST version 1.1.
- No disease progression after completion of four cycles of first-line third-generation EGFR-TKI plus chemotherapy and no unresolved grade ≥3 nonhematologic toxicity.
- Oligo-residual disease after four treatment cycles, with all residual lesions considered suitable for stereotactic radiotherapy by the investigator.
- Written informed consent.
Exclusion Criteria:
- Double primary or multiple primary malignancies, except early skin cancer or cervical carcinoma in situ treated with curative intent and without recurrence or progression for at least five years.
- Pregnancy or breastfeeding, or considered unsuitable by the investigator for PET/CT or brain MRI examination.
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder that, in the investigator's judgment, may interfere with informed consent or participant compliance.
- Residual lesions considered unsuitable for consolidative stereotactic radiotherapy after first-line third-generation EGFR-TKI plus chemotherapy.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Radiotherapy plus TKI Group
Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy.
|
administered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
cisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.
administered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.
SRS/SRT/SBRT delivered to all eligible intracranial and/or extracranial oligo-residual lesions, completed as a single course or in staged courses within one month.
|
|
Aktiv komparator: TKI alone Group
Continued third-generation EGFR-TKI and pemetrexed maintenance therapy alone.
|
administered during induction and maintenance; the specific third-generation EGFR-TKI is not uniformly restricted in the protocol.
cisplatin or carboplatin plus pemetrexed for four 3-week cycles during induction.
administered with the third-generation EGFR-TKI until disease progression or unacceptable toxicity.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsram: 4 years
|
The time from randomization to disease progression or death of the patient.
Patients who have not yet progressed at the time of analysis will be censored at the date of their last contact.
|
4 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total överlevnad (OS)
Tidsram: 4 år
|
4 år
|
|
|
Intracranial Progression-Free Survival (iPFS)
Tidsram: 4 years
|
4 years
|
|
|
Health-Related Quality of Life (HRQoL)
Tidsram: 4 years
|
health-related quality of life assessed using the QLQ-C30 and QLQ-LC13 questionnaires
|
4 years
|
|
Incidence of Treatment-Related Toxicities
Tidsram: 4 years
|
proportion of evaluable participants experiencing treatment-related toxicities, graded according to CTCAE version
|
4 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
peripheral blood specimens
Tidsram: 4 years
|
This study requires that peripheral blood specimens be collected as much as possible at the time points specified in the study, and that they be stored and processed in accordance with standard procedures, in order to explore the clinical value of liquid biopsy for oligo-residual disease prediction, early warning of drug resistance, and prognostic assessment.
|
4 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 september 2030
Avslutad studie (Beräknad)
1 september 2030
Studieregistreringsdatum
Först inskickad
7 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
10 september 2026
Första postat (Faktisk)
16 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LUNG-SORT2
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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