Clinical trial · Interventional
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
NCT02103257CI-TRIAL-00017691unknownPhase 4ClinicalTrials.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)
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| EGFR Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
| Sequential Icotinib Plus Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sequential icotinib plus chemotherapy
- description
- Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
- interventionNames
- Drug: Sequential Icotinib Plus Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Icotinib
- description
- Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) * Patients must have previously untreated locally advanced or metastatic NSCLC * EGFR activating mutation (exon 19 deletion, L858R) is required * Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 Exclusion Criteria: * Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR * Patients with wild-type EGFR * Any other investigational agents are not permitted * Any evidence of interstitial lung disease
References
Publications (0)
Data not yet available
No reference posted for this study.