Clinical trial · Interventional
Stereotactic Body Radiation Therapy (SBRT) in Newly Diagnosed Advanced Staged Lung Adenocarcinoma (Sindas)
Tyrosine-kinase Inhibitor (TKI) With or Without SBRT in Newly Diagnosed EGFRm Advanced Staged Lung Adenocarcinoma
NCT02893332CI-TRIAL-00049843SindasterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After interim analysis, IRB recommend termination.
Summary
Brief summary (as posted)
To tested if the adding of consolidative SBRT to TKI in EGFR mutated patients with less than or equal to 5 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to TKI alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV EGFR Mutated Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma with EGFR Mutation | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: SBRT | Radiation | — | UNRESOLVED |
| TKI (Gefitinib or Tarceva ) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TKI without SBRT
- description
- Newly diagnosed Patients will be placed on EGFR-TKI, ,Gefitinib 250mg po qd or Tarceva 150mg po qd for their metastatic EGFR-mutant stage IV oligometastatic disease. The oligometastatic disease will not receive SBRT
- interventionNames
- Drug: TKI (Gefitinib or Tarceva )
- type
- EXPERIMENTAL
- label
- TKI with SBRT
- description
- experimental: Oligometastatic Non-Small Cell Lung Cancer Newly diagnosed patients will be placed on EGFR-TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will TKI, Gefitinib 250mg po qd or Tarceva 150mg po qd, and SBRT at the same time. SBRT to up to 5 sites. The SBRT dose range from 5 Gy per fraction to 8 Gy per fraction. SBRT deliver within 5 fractions.
- interventionNames
- Radiation: Radiation: SBRT
- Drug: TKI (Gefitinib or Tarceva )
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion): * all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology * all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion. * No brain metastasis is allowed. * Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib. * Lung adenocarcinoma histology confirmed * Karnofsky Performance Status ≥ 70% * Adequate bone marrow, liver and renal function, as specified below: * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L * Hemoglobin ≥ 8 g/dL * Platelets ≥ 100 x 109/L * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome) * AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present * Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter Exclusion Criteria: * Treatment with TKI prior to developing metastatic disease * Malignant pleural effusion or pleural disease * Leptomeningeal disease or brain metastasis. * Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy * Women who are breastfeeding or pregnant * Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment. * Any medical co-morbidities that would preclude surgery or radiation therapy
References
Publications (1)
- DERIVEDWang XS, Bai YF, Verma V, Yu RL, Tian W, Ao R, Deng Y, Zhu XQ, Liu H, Pan HX, Yang L, Bai HS, Luo X, Guo Y, Zhou MX, Sun YM, Zhang ZC, Li SM, Cheng X, Tan BX, Han LF, Liu YY, Zhang K, Zeng FX, Jia L, Hao XB, Wang YY, Feng G, Xie K, Lu Y, Zeng M. Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated Non-Small Cell Lung Cancer. J Natl Cancer Inst. 2023 Jun 8;115(6):742-748. doi: 10.1093/jnci/djac015. PMID 35094066