Clinical trial · Interventional
Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC
Targeted Induction Therapy for Stage III Unresectable EGFR Mutant Positive NSCLC: a Single-center, Randomized Controlled Trial
NCT07742332CI-TRIAL-00120370recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The subjects of this study are patients with unresectable stage III non-small cell lung cancer (NSCLC) who have EGFR mutations.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| EGFR | — | UNRESOLVED | — |
| Locally Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent Radiochemotherapy | Combination Product | — | UNRESOLVED |
| Fumetinib combined platinum-based double chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fumetinib combined platinum-based double chemotherapy
- description
- Fumetinib combined platinum-based double chemotherapy
- interventionNames
- Drug: Fumetinib combined platinum-based double chemotherapy
- type
- PLACEBO_COMPARATOR
- label
- Concurrent Radiochemotherapy
- description
- Concurrent Radiochemotherapy
- interventionNames
- Combination Product: Concurrent Radiochemotherapy
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy; * At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS; * No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.); * With the feasibility to receive radical surgery ; * Good lung function that could tolerate surgical treatment; * Minimum age: 18 years; * At least one measurable tumor foci (the longest diameter measured by CT shall be \> 10 mm); * Other major organs shall function well (liver, kidney, blood system, etc.): * ECOG PS score shall be 0-1; * The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial; * The patient shall sign the Informed Consent Form. Exclusion Criteria: * The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.; * The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ Grade II specified by New York Heart Association (NYHA)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment; * The patient is a carrier of HIV; * The patient has had or is currently suffering from interstitial lung disease; * The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial; * The patient is allergic to befotertinib or its any excipients; * The patient is allergic to bevacizumab or its any excipients; * The patient is allergic to platinum-based double chemotherapy or its any excipients; * The female patient is in pregnancy or lactation period; * There are any conditions under which the investigator considers the patient is not suitable to be enrolled.
References
Publications (0)
Data not yet available
No reference posted for this study.