The PADL1NK-005 Clinical Trial is a phase 3, open label study evaluating the antibody drug conjugate (ADC) SGN-PDL1V versus docetaxel in adult participants with previously treated PD-L1 positive non-small cell lung cancer (NSCLC).
About the study medicine
PD-L1 is a protein found in human cells which stops the body’s immune system from attacking its own healthy cells, but it is also found in some cancers. The PADL1NK-005 clinical trial is exploring a study medicine which is designed to target PD-L1 on tumor cells and deliver an anticancer drug to eliminate them.
PADL1NK-005 is enrolling NSCLC patients aged 18 or older who:
Have a confirmed diagnosis of NSCLC that is locally advanced, unresectable (Stage IIIB/IIIC), not eligible for definitive chemoradiotherapy or metastatic (Stage IV)
- Laboratory test abnormalities as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, and timing
Have received previous therapies and either progressed during or relapsed after their most recent prior therapy. Previous therapies may include:
- Platinum-based combination therapy
- PD-1 or PD-L1 monoclonal antibody
- AGA-targeted therapy (for patients with known AGAs)
Have PD-L1 expression on ≥1% of tumor cells
AGA, actionable genomic alterations; PD-1, programmed cell death receptor 1; PD-L1, programmed cell death ligand 1
Approximately [680] participants will be randomly assigned on a 1:1 basis to either:
- SGN-PDL1V 1.5 mg/kg adjusted ideal body weight IV on Days 1 and 8 of 21-day cycles.
- Docetaxel monotherapy 75 mg/m2 IV on Day 1 of 21-day cycles.
The duration of the study may be up to 5 years for each participant.
- This will include:
- Screening Period (1 screening visit + 1 baseline visit)
- Treatment Period (1-2 visits per 3-week cycle + 1 End of Treatment visit)
- Follow-up Period (1 safety follow-up visit + long-term follow-up calls every 6-12 weeks)
People are often introduced to the world of clinical trials through conversations with their healthcare provider. As with anything new, there may be a number of questions, concerns, or misconceptions. Being their trusted healthcare provider, we appreciate you taking the time to have an open discussion with patients and their loved ones who may be interested in contributing to research.
Clinical trials may be an option that your patients will want to consider. While no benefit is guaranteed from an investigational medicine, your patients who participate in a clinical trial will contribute to the process of developing a potential new therapy.
If you would like more study-specific information to help inform conversations with potential participants, please let us know. You can find details to contact your nearest study sites in the list above. Should any of your patients take part in this clinical trial, they will remain under your medical care for all non-study-related needs and will continue to receive any benefits to which they are entitled.
To keep the line of communication open between you and your patients, feel free to follow up with them to see if they are randomized into this clinical trial and to keep in touch with them throughout their study journey.
Pfizer will give clinical trial participants the option to access certain individual data, approximately 12 months after study completion. This allows participants to share data with their healthcare provider after their study participation concludes.