Trastuzumab Deruxtecan + Pembrolizumab for Lung Cancer
(DESTINY-Lung06 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new drug combination for treating non-squamous non-small cell lung cancer. It compares trastuzumab deruxtecan (a targeted therapy) and pembrolizumab (an immunotherapy drug) with traditional chemotherapy plus pembrolizumab. The trial focuses on individuals who have not yet received treatment for their advanced lung cancer, particularly those with tumors that have specific features (HER2-overexpressing and a PD-L1 TPS less than 50%) not addressed by other available treatments. This trial may suit someone with untreated advanced lung cancer whose daily life is affected by the disease. As a Phase 3 trial, it represents the final step before FDA approval, offering participants access to potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that trastuzumab deruxtecan (T-DXd) works well for patients with advanced HER2-positive or low cancers. It has led to strong and lasting improvements in those who have undergone previous treatments. Reports indicate that the safety of T-DXd is generally as expected, although a lung condition called interstitial lung disease (ILD) has been noted as a side effect.
Pembrolizumab, a common cancer treatment, is generally well-tolerated. It is already approved for use in various cancers, indicating that its safety is well understood.
Overall, the combination of these treatments has been tested. While side effects like ILD occur, they align with past patient experiences.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Trastuzumab Deruxtecan (T-DXd) with Pembrolizumab for lung cancer because T-DXd is a targeted therapy that specifically attacks cancer cells expressing the HER2 protein. Unlike other treatments that generally target all rapidly dividing cells, this combination aims to deliver chemotherapy directly to cancer cells, minimizing damage to healthy cells. On the other hand, the combination of Pemetrexed, platinum-based chemotherapy, and Pembrolizumab in the comparator arm is already a standard treatment, but it does not offer the targeted approach that T-DXd provides. The hope is that this unique mechanism will result in more effective treatment with potentially fewer side effects.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that a combination of two drugs, trastuzumab deruxtecan (T-DXd) and pembrolizumab, may be promising for treating non-small cell lung cancer (NSCLC) with high levels of HER2. In this trial, participants in Arm A will receive this combination. Early studies found that patients with this cancer type responded well to the drug combination, especially those not previously treated with immune checkpoint inhibitors. These inhibitors help the immune system fight cancer. This suggests that the combination might outperform standard treatments for this specific cancer type. However, while the early results are encouraging, further research is needed to confirm these findings.678910
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-squamous lung cancer that overexpresses HER2 and hasn't spread widely. They haven't had systemic cancer treatment for this condition but may have had certain other therapies if it's been 6 months since the last dose without disease progression. Participants need a recent or new biopsy showing HER2 and PD-L1 levels, must sign consent forms, and can't have specific gene alterations treatable by existing drugs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either T-DXd plus pembrolizumab or Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab
Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Pemetrexed
- Trastuzumab Deruxtecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University