NewsResearch
LAURA Trial: Osimertinib for Stage III Lung Cancer
The LAURA trial led FDA to approve osimertinib after chemoradiation for unresectable stage III EGFR-mutated lung cancer. What the numbers show and don't.
Original commentary from the Cancer Explained editorial team.
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.
Stage III non-small cell lung cancer that cannot be removed by surgery is usually treated with chemoradiation. That means chemotherapy and radiation given as one combined course. The LAURA trial tested what should happen next for one specific group. These are people whose tumors carry certain EGFR mutations. The result was striking enough that on September 25, 2024, the FDA approved osimertinib (Tagrisso) for this setting.
What the trial tested
Osimertinib is a once-daily pill that blocks the signal from a mutated EGFR gene. It was already used in earlier-stage and metastatic EGFR-mutated lung cancer. LAURA asked whether taking it after chemoradiation would keep unresectable stage III cancers from progressing.
The trial enrolled 216 adults and randomly assigned them, two to one, to osimertinib or placebo. It was double-blind: neither patients nor doctors knew who was getting the drug.
Exactly who the approval covers
The FDA indication is narrow. It covers adults with locally advanced, unresectable (stage III) non-small cell lung cancer. Their disease must not have progressed during or following platinum-based chemoradiation. And their tumors must have EGFR exon 19 deletions or exon 21 L858R mutations.
Every part of that sentence is a gate. The cancer is stage III and not operable. Chemoradiation came first and held the cancer in check. In the trial, people enrolled without progression, within 42 days of chemoradiation. And the tumor must carry one of those two specific EGFR mutations, found by biomarker testing. If a tumor has not been tested for EGFR mutations, this result cannot be applied to it.
What the trial showed
The primary endpoint was progression-free survival (PFS): how long people lived without the cancer growing. The difference was large. Median PFS was 39.1 months with osimertinib versus 5.6 months with placebo. The hazard ratio was 0.16, with a 95% confidence interval of 0.10 to 0.24. That means an 84% lower relative risk of progression or death during follow-up.
Few targeted-therapy trials show a gap this wide. The practical message: EGFR test results now change treatment in stage III disease, not just stage IV.
What the trial has not shown
PFS is not proof of living longer. At the time of the approval, overall survival data were immature. Only 36% of the deaths needed for a proper analysis had occurred. FDA noted no trend toward harm. But whether osimertinib after chemoradiation extends life, rather than delaying progression while it is taken, is not yet answered.
There is also a built-in tradeoff to discuss with a care team. Starting the pill right away means taking a daily drug, with its side effects, during time that would otherwise be treatment-free.
Side effects
In the trial, the most common adverse reactions affected at least 20% of people. They were lowered white blood cell counts (lymphopenia, leukopenia, neutropenia) and low platelets. They also included lung inflammation (interstitial lung disease, or pneumonitis), rash, diarrhea, nail changes, musculoskeletal pain, cough, and COVID-19 infection. Lung inflammation deserves special attention. It was among the most common reactions, in people who had all just received chest radiation. New or worsening breathlessness or cough on this drug is a call-the-team symptom, not a wait-and-see one.
The approved dose in the label is 80 mg once daily, with or without food. As with any label figure, follow the prescription your own team gave you. Treatment continues until the disease progresses or side effects become unacceptable.
What to raise with the team
- Has my tumor had biomarker testing, and does the report show an EGFR exon 19 deletion or L858R mutation?
- I finished chemoradiation without progression. Does the approval's timing window apply to me?
- What is the plan for watching my lungs, and which symptoms should trigger a same-day call?
- How long would I stay on osimertinib, and what happens if the cancer progresses while I am on it?
- What do we know so far about whether this drug helps people in my situation live longer?
What this does not mean
- It does not apply to stage III lung cancers without an EGFR exon 19 deletion or L858R mutation, which are the majority.
- It does not replace chemoradiation. Osimertinib here comes after it, not instead of it.
- It is not yet proof of longer life. The trial showed a large delay in progression; survival data were immature at approval.
- It does not cover operable stage III disease or other treatment sequences that the trial did not test.
Sources
Know someone who needs this?
Plenty of people are looking for something like this and do not know where to start. If this would help a friend or someone you love, send it on — we have written an opening line so you do not have to stare at an empty message. You can change every word of it.
Your message is written and sent in your own email or messaging app — we never see who you send it to, and nothing is added to any list.
Put the story in context
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.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.