Trial Results: ECOG-ACRIN research round-up – Fall 2025

Below, we highlight results from clinical trials by the ECOG-ACRIN Cancer Research Group and PrECOG, LLC that were recently published in medical journals or reported at scientific meetings. These studies demonstrate progress toward developing more effective treatments and enhancing the quality of life for cancer patients.

Breast Cancer – A potential new treatment for HR+, HER2- metastatic breast cancer

• Hormone receptor–positive (HR+), HER2-negative (HER2−) breast cancer is the most common subtype. While there are many effective treatments, some patients may develop metastatic disease, making it harder to treat. For example, immunotherapy, which uses the patient's own immune system to target cancer cells and eliminate them, has not shown much effectiveness so far. A small clinical trial, BRACELET-1, tested combinations of cancer drugs to see if they could enhance the effectiveness of immunotherapy. Promising results were observed with a unique immunotherapy called pelareorep (pel-a-REE-oh-rep) and paclitaxel (PA-klih-TAK-sil) chemotherapy. This combination resulted in longer survival without the disease getting worse, compared to the other combinations studied in the trial. Researchers suggest further study in a larger clinical trial, with careful attention to side effects. Read the press release to learn more about how this new treatment could possibly keep the disease at bay longer than before.

Ductal Carcinoma in Situ – Study finds declines in mental health 2 years after surgery

• Ductal carcinoma in situ (DCIS), sometimes called stage 0 breast cancer, is not invasive and not life-threatening. Most women with DCIS successfully have their cancer removed. Their prognosis is excellent, with a 98% survival rate 10 years after treatment. However, are certain patients more vulnerable than others to a decline in mental well-being after treatment? The answer is ‘yes’ according to a newly published analysis. It is based on patient surveys, and it reveals that minority racial identity, non-private insurance, and more surgery (such as a follow-up mastectomy) were all associated with poorer mental and physical health 2 years after surgery. Researchers studied patient-reported outcomes from a prior treatment trial (E4112), which included women with DCIS in one breast. Participants completed questionnaires before surgery, at the first post-operative visit, and 1 and 2 years after surgery. Don’t miss this news interview with Dr. Lynne Wagner, who explains how this study gets to the heart of the issues women with DCIS face after treatment and identifies those at greatest risk. She emphasizes the importance of ongoing monitoring of mental well-being over time—well beyond the completion of treatment.

Leukemia – Immunotherapy in the treatment of young adults with B-ALL

• We know that combining the immunotherapy drug blinatumomab (blih-nuh-TOO-moh-mab) with chemotherapy significantly improves overall survival for adult patients with B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer, that has gone into remission following initial treatment. This discovery is from the E1910 trial, which studied the treatment in patients aged 30-70 years. The study changed clinical practice and helped lead to an FDA approval of the treatment. Recently, researchers reported survival rates for the under-55 subgroup and, more narrowly, the 30-39 age group. They confirmed a substantial survival benefit with blinatumomab and chemotherapy in younger adults. Their finding is consistent with separate studies in adolescents and young adults. Watch this video interview with Dr. Shira Dinner to hear how this treatment is boosting survival and shaping the future of care for young adults with this disease.

Lung Cancer – Treatment headway gives much-needed hope

• Small-cell lung cancer (SCLC) is an aggressive cancer that often spreads quickly and is associated with high recurrence rates after initial treatment. When diagnosed at an advanced stage, SCLC has spread too far for surgery or radiation therapy to be helpful as the initial treatment. A small clinical trial, EA5161, explored giving the immunotherapy drug nivolumab (nih-VOL-yoo-mab) to patients with untreated extensive-stage SCLC in combination with chemotherapy. This approach was compared to chemotherapy alone. The published results show that nivolumab plus chemotherapy was better at helping patients live longer without the disease getting worse. 

Lung Cancer – Crizotinib targeted therapy did not improve survival for early-stage ALK+ patients

• About 1 in 25 people with non-small cell lung cancer have tumors with an ALK gene change. The ALCHEMIST E4512 study tested whether the targeted drug crizotinib (krih-ZOH-tih-nib) could help people with early-stage ALK+ disease live longer after surgery. At a recent medical meeting, researchers reported that crizotinib did not improve survival compared with observation alone—the standard approach after surgery—and caused more side effects. They noted that newer ALK drugs have been developed since this trial began, which appear to be more effective and have fewer side effects. Watch Dr. David Gerber’s trial presentation video to hear how these drugs offer hope for improving outcomes in the future.

Lung Cancer – Starting immunotherapy during chemotherapy and radiation did not help patients live longer 

• For people with stage 3 lung cancer that cannot be removed by surgery, standard treatment is chemotherapy and radiation, followed by a year of immunotherapy with durvalumab (dur-VAL-yoo-mab). The EA5181 trial tested whether starting durvalumab earlier—during chemotherapy and radiation—could help patients live longer. Researchers reported at a recent medical meeting that the study found no added benefit from giving durvalumab at the same time as chemo and radiation. Doctors continue to recommend durvalumab after chemo and radiation, not during it. To learn more, watch a trial presentation video with Dr. John Varlotto.

Nose and Sinus Cancer – Chemotherapy before surgery helps patients avoid debilitating eye and bone removal

• A striking improvement was observed in patients who received chemotherapy before surgery to remove nose and sinus cancer. Patients enrolled in the EA3163 trial had signs that surgery would result in loss of the eye, the base of the skull bone, or both. This study found that the group that received chemotherapy before surgery had a 50% chance of preserving these organs. In contrast, patients who only had surgery—the usual treatment—had a much lower 15% chance. Read the press release with Dr. Nabil Saba to learn how pre-surgery treatment is dramatically increasing the chances of preserving vision and critical bone structure.

Skin Cancer – Immunotherapy after surgery shows potential in preventing the spread of aggressive skin cancer

• A drug that uses the body’s immune system to target and eliminate cancer cells appeared to reduce the risk of risk of the cancer spreading to other parts of the body for an aggressive form of skin cancer when given immediately after surgery, but did not significantly reduce the overall risk of recurrence, which was a co-primary endpoint of the trial. The STAMP trial (EA6174) is the largest study to evaluate immunotherapy with pembrolizumab (pem-broh-LIH-zoo-mab) after surgery to remove the cancer. This is much-needed good news for people who are living with the highly aggressive cancer known as Merkel cell carcinoma. Read the press release with Dr. Janice Mehnert to learn more about the hope this brings for those suffering from this disease.

Throat Cancer – Excellent long-term outcomes after less intense treatment

• E3311 is a clinical trial that improved treatment for patients with human papillomavirus (HPV+) associated throat cancer and at medium risk for recurrence. The trial showed the benefits and safety of providing low-dose radiation without chemotherapy after surgery. Now, the published long-term results continue to show excellent outcomes, with 90% of the patients being cancer-free after 4 ½ years. Not only does this less-intense treatment approach achieve very high survival, but it also delivers an outstanding quality of life for patients. For example, it preserves patients’ swallowing and voice functions and spares them unnecessary side effects. To learn more about how this trial has helped patients, read the lay-friendly trial summary and the original press release.