- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07822984
Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant NSCLC After First-Line Third-Generation EGFR-TKI Plus Chemotherapy
10. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
374
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse (OS)
Tidsramme: 4 år
|
4 år
|
|
|
Intracranial Progression-Free Survival (iPFS)
Tidsramme: 4 years
|
4 years
|
|
|
Health-Related Quality of Life (HRQoL)
Tidsramme: 4 years
|
health-related quality of life assessed using the QLQ-C30 and QLQ-LC13 questionnaires
|
4 years
|
|
Incidence of Treatment-Related Toxicities
Tidsramme: 4 years
|
proportion of evaluable participants experiencing treatment-related toxicities, graded according to CTCAE version
|
4 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
peripheral blood specimens
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. september 2030
Studieafslutning (Anslået)
1. september 2030
Datoer for studieregistrering
Først indsendt
7. august 2026
Først indsendt, der opfyldte QC-kriterier
10. september 2026
Først opslået (Faktiske)
16. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LUNG-SORT2
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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