The LAURA Trial May Lead to a New Era of Care in Lung Cancer

Treatment with osimertinib (Tagrisso), as seen in the phase 3 LAURA trial, has emphasized the agent as a new standard of care for patients with unresectable, locally advanced EGFR-mutated non-small cell lung cancer (NSCLC) based on key survival end point improvements, according to Dr. Suresh Ramalingam, a medical oncologist and executive director of Winship Cancer Institute of Emory University.

To further discuss this topic, Ramalingam sat down for a Q&A-style interview with CURE where he highlighted the notable findings from the LAURA trial for patients with NSCLC.

“While we have good treatments now and still have work to do, our current position offers much more hope to patients than where we were five to ten years ago,” he explained.

Furthermore, in the interview, Ramalingam also explained how Tagrisso is ushering in a wave of new therapeutic approaches for patients within this population, and what new and unique side effects are expected to come with the treatment.

Ramalingam also serves as the associate vice president for cancer of Woodruff Health Sciences Center and holds the Roberto C. Goizueta Distinguished Chair for Cancer Research. Recently, in May of 2025, Ramalingam was also listed on the TIME100 Health 2025 list for his contributions to lung cancer research.

CURE: To start, can you go over the LAURA trial. What was the rationale for this research?

Ramalingam: The LAURA trial was conducted specifically to answer an important question: For patients with stage 3 lung cancer whose cancer cannot be removed by surgery, we currently use chemotherapy and radiation as a standard of care. More recently, we have added immunotherapy to that treatment paradigm. However, we've learned over the past few years that for patients who have an EGFR mutation, immunotherapy is not very effective. On the other hand, targeting the EGFR by using a drug like Tagrisso is highly effective. So, we wanted to see whether, after chemotherapy and radiation, giving Tagrisso to patients with an EGFR mutation would result in better outcomes.

Stage 3 lung cancer is diagnosed in approximately 25% to 30% of patients with lung cancer. Among those with stage 3, a small subset of patients can undergo surgery. For the others, because the tumor is advanced or they have many lymph nodes involved, surgery does not help them, and chemotherapy and radiation are used. We refer to this as unresectable, locally advanced stage 3 NSCLC. It was for this particular patient population that the LAURA study was conducted.

What recent findings were shared regarding the LAURA trial?

About a year ago, we presented the first results of the LAURA study. When comparing the use of Tagrisso versus placebo after patients had completed chemotherapy and radiation, we observed a significant improvement in progression-free survival. For instance, in the progression-free survival data, patients treated with Tagrisso had nearly 39 months where the cancer remained under control, compared to only about five and a half months in the control group (patients who did not receive Tagrisso). This was a large, statistically significant, and clinically very meaningful difference, and these results formed the basis for the FDA's approval of Tagrisso in this setting. So, it is now an FDA-approved drug for unresectable, locally advanced NSCLC.

What we reported recently are some additional data on the impact of Tagrisso therapy on patient overall survival. This result is still not mature; it's going to take us a couple more years before we fully understand its impact. However, at this preliminary look, we see a very favorable trend towards improvement in survival for patients treated with Tagrisso. Overall survival is obviously one of the key endpoints. Earlier, we showed that Tagrisso prolongs the time the cancer remains under control. To add that benefit with a potential improvement in survival makes it even more meaningful for patients with locally advanced NSCLC. So, that's the most recent update: a very encouraging survival trend. When we reported the first survival results last year, we saw a favorable trend. This year, with more follow-up, that trend looks even more positive.

The LAURA trial demonstrated an improved overall survival trend in patients with unresectable Stage III EGFR-mutated NSCLC. What is significance of these findings within the current treatment landscape?

Until now, and prior to the recent FDA approval, the standard treatment for patients with locally advanced, unresectable stage 3 lung cancer, even those with an EGFR mutation, consisted of chemotherapy and radiation. While some physicians used immunotherapy, we've observed that immunotherapy does not offer a significant benefit in this specific patient group.

With the results of this trial, we can now use Tagrisso after patients have completed chemotherapy and radiation, provided they have derived some benefit from the initial combined therapy. This treatment is now FDA-approved in the U.S. and is being incorporated into routine practice. I suspect it will be gradually adopted in practice in many other parts of the world as well.

We've also seen a Chinese drug, which has some similarities to Tagrisso, being tested in the stage 3 population, much like our study. Those results also showed favorable outcomes, clearly suggesting that using an EGFR inhibitor in this particular setting is clinically meaningful.

Interstitial lung disease and pneumonitis were observed in over half of patients treated with Tagrisso in the LAURA study. What considerations should oncologists keep in mind regarding risk management and patient selection?

One of the unique aspects of the stage 3 disease patient population is that these patients are treated with chemotherapy and radiation. A common side effect of radiation is pneumonitis, or lung inflammation. When Tagrisso is added to this regimen, a concern arose about whether it would worsen this side effect.

The findings of the LAURA study were reassuring in this regard. In the patient population that received both placebo and Tagrisso, the most common side effect was radiation pneumonitis, even with Tagrisso exposure. While there were numerically slightly more cases of radiation pneumonitis reported in the Tagrisso group, they were relatively mild. None were severe enough to fundamentally change how we think about the role of Tagrisso in this setting.

So, the key takeaway is that radiation pneumonitis can occur after chemotherapy and radiation. Physicians and patients need to be aware of this. If patients develop symptoms like worsening shortness of breath, increased cough, or fever, they need to report it to their physician. In most instances, these symptoms can be easily treated with a short course of steroids, and the symptoms should improve. In fact, in the LAURA study, when we had to interrupt treatment with Tagrisso, we were able to resume it in a high majority of patients after their symptoms improved.

Tagrisso is increasingly positioned as a backbone therapy across multiple settings in EGFR-mutated NSCLC. How do the LAURA findings support this role, particularly in earlier-stage, unresectable disease?

In metastatic NSCLC, or stage 4 NSCLC, Tagrisso is now the preferred first-line therapy. Some newer studies show that combining Tagrisso with chemotherapy can improve outcomes. There is also another regimen that includes Lazcluze (lazertinib), an Tagrisso-like drug, with another drug called Rybrevant (amivantamab-vmjw), which has shown improved survival.

While there are some options available, they all rely on the fact that a third-generation drug like Tagrisso is the mainstay of treatment.

Now, about three or four years ago, we learned that Tagrisso also improves survival for patients with early-stage lung cancer who undergo surgical resection. So, it is now the standard of care in what we call the adjuvant therapy setting. The only group where we weren't clear was those patients who did not have stage 4 disease and did not have surgically operable disease — the unresectable patient population. That is exactly the group the LAURA study evaluated.

So, Tagrisso is now basically applicable for practically every stage of NSCLC, perhaps with the exception of stage 1A, where it is still being studied. You are correct in your reference that this is now the mainstay of treatment for EGFR-mutated patients with lung cancer in the United States.

What additional data from the LAURA trial’s final analysis will be most critical to further validate Tagrisso role in this setting?

We're obviously interested in finding out the ultimate impact on patient lifespan from using this form of therapy. Our goal is for patients to live longer, live better, and live well. When the LAURA study results are mature, we will have an answer to that question. As I mentioned earlier, the trends we've seen so far are encouraging.

We're also interested in other biomarkers. For example, can we use peripheral blood and sequence tumor DNA from the peripheral blood to determine who needs therapy and who may not? These sorts of questions are being addressed by ongoing studies using samples collected from patients who participated in the LAURA trial. We're also exploring other studies to see if we can use Tagrisso before chemotherapy and radiation to try and improve the impact of this drug in this disease. All of these are ongoing questions, and we look forward to finding out the answers in the upcoming months and years.

Looking ahead, how do you see the results of LAURA influencing ongoing or future clinical trials aimed at optimizing the treatment of EGFR-mutated NSCLC, especially in the locally advanced setting?

I'd like to make two key points. First, we know there are highly effective therapies for patients with EGFR-mutated lung cancer, whether it's stage 1b, 2, 3, or 4. However, you won't know if you have an EGFR mutation unless it's tested. Therefore, it's absolutely critical that patients with NSCLC undergo molecular testing. This allows us to understand the specific molecular characteristics of their cancer, so we can implement the most appropriate therapy. It could be EGFR, ALK, or something else. The importance of testing is a crucial message I want to convey to our audience.

Second, specifically regarding locally advanced, NSCLC: when lung cancer is diagnosed, it brings a lot of stress. Patients are trying to learn about their diagnosis and various treatment options. For those with an EGFR mutation, having access to these effective therapies — which offer excellent efficacy and hopefully fewer side effects — provides significant reassurance as they begin their treatment journey.

While we have good treatments now and still have work to do, our current position offers much more hope to patients than where we were five to ten years ago.

Transcript has been edited for clarity and conciseness.

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