Trial to Investigate If Novel Drug Combo Can Boost Outcomes in Lung Cancer


A phase 3 trial will test datopotamab deruxtecan in combination with Keytruda with or without chemotherapy for certain patients with metastatic non-small cell lung cancer.

A phase 3 trial will investigate datopotamab deruxtecan in combination with Keytruda (pembrolizumab) with or without platinum-based chemotherapy for patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has PD-L1 levels under 50% and no actionable genomic alterations.

The trial, TROPION-Lung07, recently kicked off, with the first patient being dosed with the drug combination, according to Daiichi Sankyo and AstraZeneca, the manufacturers of datopotamab deruxtecan.

“Metastatic non-squamous (NSCLC) remains a challenge because the majority of patients experience disease progression following their initial treatment, underscoring the need for more effective treatment options in the first-line setting,” said Dr. Mark Rutstein, global head of oncology clinical development at Daiichi Sankyo, in a press release. “The TROPION-Lung07 trial will assess the potential of the combination of datopotamab deruxtecan and (Keytruda) with and without chemotherapy, to evaluate whether this combination may be a more effective standard treatment option than the current standard of care for patients in the first-line setting.”

Researchers plan on enrolling approximately 975 patients in clinical trial sites throughout North America, South America, Europe, Asia and Oceania. Once enrolled, patients will be randomly assigned to one of three treatment groups:

  • Arm A: datopotamab deruxtecan plus Keytruda and platinum-based chemotherapy
  • Arm B: datopotamab deruxtecan plus Keytruda
  • Arm C: Keytruda plus pemetrexed and platinum-based chemotherapy

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The main goals of the trial are to determine if the addition of datopotamab deruxtecan improves progression-free survival, which is the time during and after treatment that patients live without their disease getting worse, as well as overall survival, which is the time from treatment until death of any cause. Researchers will also look at objective response rate (percentage of patients whose disease shrinks from treatment), duration of response, time to response and disease control rate.

Datopotamab deruxtecan is an antibody drug conjugate, which means that it is designed to carry chemotherapy to a target protein that is found on cancer cells — in this instance, TROP2 — largely sparing the healthy cells around it. Previous studies showed that the drug showed promise when given in combination with a checkpoint inhibition agent such as Keytruda.

“The combination of datopotamab deruxtecan with a checkpoint inhibitor with or without chemotherapy, has shown increased activity and a manageable safety profile in early trials, including TROPION-Lung02,” said Dr. Cristian Massacesi, chief medical officer and Oncology Chief Development Officer at AstraZeneca, in the release. “With this initiation, TROPION-Lung07 becomes the third phase 3 trial in our evaluation of these investigational combinations for the first-line treatment of patients with non-small cell lung cancer, across PD-L1 segments and tumor histologies.”

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