← Back to Search

Anti-metabolites

AK112 in combination with Pemetrexed and Carboplatin for Non-Small Cell Lung Cancer

Phase 3
Recruiting
Research Sponsored by Summit Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent
ECOG performance status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

"This trial is testing a new drug, AK112, in combination with standard chemotherapy in patients with a specific type of lung cancer who have not responded to previous treatments."

Who is the study for?
This trial is for adults with advanced non-squamous NSCLC that has worsened after EGFR-TKI treatment. Participants must be in good physical condition, have measurable cancer, and acceptable organ function. They can't join if they've had certain other cancers, serious heart conditions, immune diseases or lung issues unrelated to their cancer.Check my eligibility
What is being tested?
The study tests AK112 injection versus a placebo. Both are given alongside standard chemotherapy drugs Pemetrexed and Carboplatin. It's randomized and double-blind, meaning neither the patients nor doctors know who gets AK112 or the placebo.See study design
What are the potential side effects?
Possible side effects of AK112 may include typical reactions to immunotherapy such as fatigue, skin rash, diarrhea, liver inflammation and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
I am fully active or can carry out light work.
Select...
My lung cancer is advanced but not squamous type.
Select...
My cancer has EGFR mutations confirmed by tests.
Select...
I have been treated with EGFR inhibitors and my cancer did not respond.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS) in the ITT population
Progression-free survival (PFS)
Secondary outcome measures
AE
DoR
Number of subjects who develop detectable anti-drug antibodies (ADAs)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AK112 in combination with Pemetrexed and CarboplatinExperimental Treatment1 Intervention
Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.
Group II: Placebo in combination with Pemetrexed and CarboplatinActive Control1 Intervention
Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

Find a Location

Who is running the clinical trial?

Summit TherapeuticsLead Sponsor
10 Previous Clinical Trials
2,229 Total Patients Enrolled
AkesoIndustry Sponsor
104 Previous Clinical Trials
18,315 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of participants involved in this research trial?

"This trial necessitates the enrollment of 420 eligible patients. Participation is open at various locations such as CBCC Global Research in Bakersfield, Colorado and University of Southern California in Los Angeles, Florida."

Answered by AI

Are there numerous facilities conducting this research in North America?

"This research study is being conducted at CBCC Global Research in Bakersfield, Colorado; University of Southern California in Los Angeles, Florida; and Valkyrie Clinical Trials in Mountain View, Louisiana. Additionally, there are 63 other participating sites across various locations."

Answered by AI

Are researchers currently accepting participants for this study?

"Indeed, the details available on clinicaltrials.gov emphasize that this particular medical trial is actively seeking suitable candidates. The initial posting of this study occurred on May 4th, 2023, with the most recent update made on May 1st, 2024. In total, recruitment aims to enroll 420 participants distributed among a network of 63 sites."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The primary focus of this investigation, spanning a period of up to 2 years, is the Overall Survival (OS) within the Intention-to-Treat (ITT) population. Additional endpoints comprise monitoring the emergence of anti-drug antibodies (ADAs), evaluating Duration of Response (DoR), and assessing Adverse Events (AEs) and Serious Adverse Events (SAEs), along with significant deviations in laboratory findings."

Answered by AI

What are the safety considerations for individuals when using AK112 alongside Pemetrexed and Carboplatin?

"Based on the current clinical trial phase, which involves data supporting effectiveness and multiple instances of safety data collection, our team at Power rates the safety profile of AK112 in conjunction with Pemetrexed and Carboplatin as a 3."

Answered by AI

Who else is applying?

What site did they apply to?
CBCC Global Research
Presbyterian Intercommunity Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase III Study of AK112 for NSCLC Patients
2023. "Phase III Study of AK112 for NSCLC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06396065.
All > Pflugerville Tx > Paid Studies Pasadena
~257 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top