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IPASS: What the Lung Cancer Trial Found

IPASS showed that gefitinib helped one group of lung cancer patients and harmed another, and that clinical features could not tell them apart. It is why lung tumors are tested for EGFR mutations.

By Cancer Explained Editorial TeamPublished Updated

Original commentary from the Cancer Explained editorial team.

Three lab researchers in coats examine samples together at computer monitors in a laboratory
Three lab researchers in coats examine samples together at computer monitors in a laboratory — illustrative photograph, not of anyone named in this story.

Historical context: this page explains an event dated 2009. It was published as an explainer on July 12, 2026 and is not breaking news.

Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.

One drug, two opposite results

Most trials report an average. IPASS is remembered because its average was close to meaningless. The same tablet clearly helped one set of patients and clearly harmed another, and the only way to tell them apart was a test on the tumor.

The patients chosen by clinical hunch

1,217 people in East Asia joined. All had advanced lung adenocarcinoma and none had been treated yet. All had never smoked, or had smoked only lightly in the past. 609 received gefitinib tablets. 608 received carboplatin plus paclitaxel chemotherapy.

That selection was the assumption being tested. Doctors had noticed that never-smokers with adenocarcinoma often responded to gefitinib. IPASS asked whether picking patients that way was good enough.

The headline number

At twelve months, 24.9% of the gefitinib group were alive with the cancer not yet growing, against 6.7% on chemotherapy. Overall, gefitinib won, with a hazard ratio of 0.74 (95% CI 0.65 to 0.85; p<0.001).

Read alone, that looks like a modest win for a tablet over an infusion. It is not what happened.

The split underneath it

Tumors were tested for a mutation in the EGFR gene.

Among the 261 patients whose tumors carried the mutation, gefitinib was much better than chemotherapy (hazard ratio 0.48; 95% CI 0.36 to 0.64; p<0.001).

Among the 176 whose tumors did not, gefitinib was clearly worse (hazard ratio 2.85; 95% CI 2.05 to 3.98; p<0.001). That is close to triple the risk of the cancer growing or the person dying at any moment. Giving the tablet to that group did harm.

Side effects also differed sharply. Rash or acne (66.2%) and diarrhea (46.6%) were common with gefitinib. Nerve damage (69.9%), low white cells (67.1%) and hair loss (58.4%) were common with chemotherapy.

Why this changed how lung cancer is tested

Before IPASS, choosing a targeted drug by smoking history and tumor appearance seemed reasonable. After it, that was no longer defensible. Clinical features had picked a mixed group in which the drug both helped and harmed. Only the gene test separated them.

Every EGFR-targeted lung cancer trial since has been built on that lesson. Testing the tumor before choosing a targeted drug is now standard.

What this finding cannot tell you

  • Everyone enrolled was East Asian and a never-smoker or light smoker with adenocarcinoma. The raw response rates do not carry over to a general lung cancer population.
  • EGFR status was known for only 437 of the 1,217 people. The split rests on about a third of the trial.
  • Gefitinib is no longer the preferred EGFR drug. Later generations have replaced it.
  • It measured time before the cancer grew, not cure.

Questions about EGFR testing

  • Has my tumor been tested for EGFR, and what did it show?
  • Is there enough tissue left to test, or would I need another biopsy?
  • Are other gene changes being looked for at the same time?
  • If a targeted drug is not an option, what is?

Sources

This article was written from the sources below, which were checked on the source-check date shown above.

How this article was prepared

Prepared by Cancer Explained's AI-assisted editorial system and checked against the sources listed below. This article has not been reviewed by a healthcare professional unless a named reviewer is specifically shown.

Cancer Explained is published by the National Cancer Information Foundation as a nonprofit-oriented public-interest education project. It is not a diagnostic service, does not recommend treatments, and is not for emergencies.

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Prevention, possible warning signs, screening, and diagnosis

This story relates to Lung cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.

  • Prevention and risk reduction

    Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.

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