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Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma

One-paragraph summary

IPASS randomized 1,217 untreated East Asian patients with advanced pulmonary adenocarcinoma who were never-smokers or former light smokers to gefitinib or carboplatin-paclitaxel. The trial met its primary noninferiority/superiority framework for progression-free survival in the clinically selected population, but the practice-changing result was the qualitative treatment-by-EGFR-mutation interaction: gefitinib improved PFS in mutation-positive tumors (HR 0.48) while chemotherapy was superior in mutation-negative tumors (gefitinib HR 2.85) (PMID 19692680).

Key findings

  • Total randomized: 1,217.
  • EGFR mutation, where evaluable, separated benefit from harm.
  • Mutation-positive PFS HR for gefitinib versus chemotherapy: 0.48.
  • Mutation-negative PFS HR: 2.85, favoring chemotherapy.
  • Clinical enrichment by sex, ancestry, smoking, and histology did not replace tumor genotyping.

Limitations

  • Biomarker tissue was unavailable for a substantial fraction.
  • The population was clinically and geographically selected.
  • Comparator and subsequent-treatment patterns belong to the 2000s era.
  • First-generation EGFR inhibition does not represent modern CNS-active osimertinib.

Why it matters

IPASS converted lung adenocarcinoma from phenotype-selected empiric therapy to genotype-selected therapy. Its negative-biomarker subgroup is as important as its positive subgroup: an enriched clinical profile cannot safely substitute for molecular testing.

Cited by wiki pages

  • Overview
  • EGFR disease
  • Clinical trials landscape