WCLC 2025 - Posters & ePosters-P3.12.33 The Primary Endpoint Analysis of RELAY-Effusion; a Phase II Study of Ramucirumab Plus Erlotinib in EGFR-Mutated NSCLC With Pleural Effusion

P3.12.33 The Primary Endpoint Analysis of RELAY-Effusion; a Phase II Study of Ramucirumab Plus Erlotinib in EGFR-Mutated NSCLC With Pleural Effusion

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The RELAY-effusion study was a single-arm, phase II trial evaluating ramucirumab plus erlotinib in untreated patients with advanced or recurrent EGFR-mutated non-squamous non-small cell lung cancer (NSCLC) presenting with malignant pleural effusion (MPE). MPE is common (about 40%) in advanced NSCLC and is associated with poor prognosis. EGFR-TKI monotherapy, including osimertinib, may be less effective in this subgroup, and no standard treatment exists for EGFR-mutated NSCLC with symptomatic MPE. The study aimed to assess progression-free survival (PFS) as the primary endpoint, along with objective response rate (ORR), overall survival (OS), safety, and drainage-free survival (DFS).<br /><br />Forty patients were enrolled from December 2021 to December 2023. Median age was ~70 years, with balanced sex distribution and common EGFR mutations (Exon 19 deletions and Exon 21 L858R). Baseline treatments for MPE included aspiration or chest drainage in over half the patients.<br /><br />After a median follow-up of 24.2 months, median PFS was 12.9 months (95% CI 7.3–17.0), slightly below the expected 14 months. ORR was 77.5%, with a disease control rate of 85%. Median DFS (time without needing pleural drainage) was 31.8 months, and median OS was 33.0 months, with 12-month OS at 87.5%. Subgroup analysis suggested longer PFS in Exon 19 deletion versus L858R mutation. About 28% developed EGFR T790M resistance mutation after progression and received subsequent therapies including osimertinib.<br /><br />Treatment was generally tolerable; common adverse events included rash, decreased appetite, hypertension, and elevated liver enzymes. Dose reductions were more frequent for erlotinib than ramucirumab. Safety profiles aligned with known data for these drugs.<br /><br />In conclusion, while ramucirumab plus erlotinib did not meet the prespecified PFS efficacy goal in EGFR-mutated NSCLC with MPE, it showed favorable control of pleural effusion, suggesting clinical benefit for fluid management. Safety was consistent with known profiles. This trial fills an important knowledge gap by providing prospective data on this challenging patient population.

Asset Subtitle

Naoko Katsurada

Meta Tag

Speaker Naoko Katsurada

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

RELAY-effusion study

ramucirumab

erlotinib

EGFR-mutated non-small cell lung cancer

malignant pleural effusion

progression-free survival

objective response rate

overall survival

EGFR T790M resistance mutation

pleural effusion management