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Monoclonal Antibodies

Immunotherapy + Targeted Therapy for Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report (Sub-Study A Phase 1b & 2)
Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months)
Awards & highlights

Study Summary

This trial is testing a combination of therapies, one of which is a PD-1 antagonist monoclonal antibody. The first part of the trial (Phase 1b) is testing the safety of the combination, and the second part (Phase 2) will test how well the combination works against cancer.

Who is the study for?
This trial is for adults with advanced Non-small Cell Lung Cancer (NSCLC) who have specific genetic mutations like BRAFV600E, adequate organ function, and no prior treatments for metastatic NSCLC in certain sub-studies. It excludes those with autoimmune diseases, previous treatment with similar drugs or immunotherapy, significant heart disease, other recent cancers or certain lung conditions.Check my eligibility
What is being tested?
The study tests Sasanlimab (an immune therapy drug) combined with targeted cancer therapies like Encorafenib and Binimetinib. The first phase checks safety and dosage; the second phase assesses how well these combinations work against tumors.See study design
What are the potential side effects?
Potential side effects include typical reactions to immunotherapies such as fatigue, skin issues, inflammation of organs like the lungs or intestines, hormonal gland problems, liver toxicity and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor or blood test shows a BRAFV600E mutation.
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My lung cancer is at an advanced stage (Stage IIIB-IV).
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My liver, kidneys, and bone marrow are working well.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of study treatment until the date of the first documentation of pd (approximately 44 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b of Sub-Study A: Percentage of Participants With Dose-Limiting Toxicities (DLT)
Phase 2 of Sub-Study A: Durable Objective Response Rate (ORR)
Secondary outcome measures
Phase 1b of Sub-Study A: Area Under the Concentration Verses Time Curve Over the Dosing Interval (AUCtau) After Single Dose of Sasanlimab
Phase 1b of Sub-Study A: Ctrough of Binimetinib
Phase 1b of Sub-Study A: Ctrough of Encorafenib
+25 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sub-Study BExperimental Treatment3 Interventions
Sasanlimab will be administered subcutaneously. Axitinib will be administered orally. SEA-TGT will be administered intravenously. Treatments will be administered until progressive disease, unacceptable AE, patient withdraws, or study is terminated.
Group II: Sub-Study AExperimental Treatment3 Interventions
Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encorafenib
2021
Completed Phase 3
~960
Axitinib
2020
Completed Phase 2
~3050
Binimetinib
2018
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,839 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,007 Total Patients Enrolled

Media Library

Sasanlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04585815 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Sub-Study A, Sub-Study B
Non-Small Cell Lung Cancer Clinical Trial 2023: Sasanlimab Highlights & Side Effects. Trial Name: NCT04585815 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research the inaugural endeavor of its kind?

"At present, 110 studies concerning Sasanlimab are still active across 45 different nations and 1353 cities. First initiated in 2011 by Pfizer with a Phase 2 trial of 39 participants, 108 additional investigations have since been undertaken."

Answered by AI

How many participants are being included in this experiment?

"To make this trial a success, 375 patients that satisfy the inclusion criteria need to enroll. Ophthalmic Consultants of Boston Inc (OCB) in Boston and Florida Cancer Specialists in Ocala are two locations offering participation opportunities."

Answered by AI

What ailments does Sasanlimab generally target?

"Sasanlimab is frequently used as a therapeutic for metastatic melanoma, however its effectiveness extends to other medical issues such as advanced thyroid cancer, unresectable melanoma and aplastic anemia."

Answered by AI

What other research projects have been conducted relating to Sasanlimab?

"Currently, 110 Sasanlimab studies are active with 8 in the third phase of trials. Cambridge, England has multiple sites running these experiments whereas other locations throughout the world offer a total of 4474 clinical study options for this drug."

Answered by AI

Is the enrollment period for this research still open?

"Per the information available on clinicaltrials.gov, this research program is currently in search of participants. It was initiated on November 10th 2020 and its details were updated as recently as November 17th 2022."

Answered by AI

In which locales is this research study taking place?

"The aforementioned medical trial is taking place at Ophthalmic Consultants of Boston Inc (OCB) in the state of Massachusetts, Florida Cancer Specialists situated in Ocala, and Dana-Farber Cancer Institute located in Aurora. Additionally, other 90 sites are participating across America."

Answered by AI

Who else is applying?

What site did they apply to?
Henry Ford Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
2020. "Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585815.
All > Non Small Cell Lung Cancer > Inlyta
~8 spots leftby Apr 2025
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