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Monoclonal Antibodies

Avelumab for Non-Small Cell Lung Cancer (SPRING Trial)

Phase 1 & 2

Waitlist Available

Led By RAZELLE KURZROCK, MD

Research Sponsored by Worldwide Innovative Network Association

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

SPRING Trial Summary

This trial will test a combination of three drugs to treat non-small cell lung cancer that has spread and does not have any known mutations that could be targeted.

Eligible Conditions

Non-Small Cell Lung Cancer

SPRING Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Duration of the Response

Incidence of the Tested 3-Drug Combination Therapy-Emergent Adverse Events and Serious Adverse Events

Overall Survival (OS)

+3 more

Secondary outcome measures

Genomic and Transcriptomic Profile

Incidence of Treatment-related and or Biopsy-related Serious Adverse Events

SPRING Trial Design

1Treatment groups

Experimental Treatment

Group I: Avelumab, Axitinib, PalbociclibExperimental Treatment3 Interventions

For the Phase 1: Avelumab is administered intravenously (IV) on Day 1 and Day 15 of a 28 day cycle in combination with axitinib po bid (every day of a 28 day cycle) and palbociclib po (on days 8-28 of a 28 day cycle). For the Phase 2: Avelumab, axitinib and palbociclib are administered at the recommended phase 2 dose (RP2D) as determined during the phase 1 part of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

FDA approved

Palbociclib

FDA approved

Axitinib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Worldwide Innovative Network AssociationLead Sponsor

ARC Foundation for Cancer ResearchOTHER

6 Previous Clinical Trials

3,335 Total Patients Enrolled

PfizerIndustry Sponsor

4,568 Previous Clinical Trials

10,911,871 Total Patients Enrolled

Frequently Asked Questions

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

How is Avelumab most often used?

"Avelumab is an approved cancer medication for the treatment of breast cancer, Merkel cell carcinoma, and other malignant neoplasms."

Answered by AI

Are there any unfilled vacancies for individuals in this research project?

"This trial is no longer recruiting patients. The listing says it was first posted on 29 November 2017 and the last update was on 12 August 2020. If you are interested in other trials, there are 1948 other studies recruiting patients with malignant neoplasms and 283 trials for Avelumab that are still enrolling participants."

Answered by AI

Avelumab has been studied in the past, correct? Could you please elaborate on these previous studies?

"At the moment, there are 283 active studies and 29 trials in Phase 3 investigating Avelumab. Most of the clinical trials for Avelumab are located in Burgas, New jersey, but there are a total of 10842 locations running trials for Avelumab."

Answered by AI

Are there any other similar ongoing clinical trials?

"Avelumab has been under investigation since 2011, when the first Phase 1 clinical trial began. This original trial was conducted by Pfizer and had 39 participants. Avelumab received Phase 2 approval after this initial study. As of now, there are 283 ongoing studies involving Avelumab that are hosted in 1694 cities and 62 countries."

Answered by AI

Recent research and studies

Cancer MedicineJournal

A <scp>win</scp> Consortium Phase I Study Exploring Avelumab, Palbociclib, and Axitinib in Advanced Non‐small Cell Lung Cancer

Solomon, Benjamin, Ana Callejo, Jair Bar, Guy Berchem, Lyudmila Bazhenova, Pierre Saintigny, Fanny Wunder, et al.. 2022. “A win Consortium Phase I Study Exploring Avelumab, Palbociclib, and Axitinib in Advanced Non‐small Cell Lung Cancer”. Cancer Medicine. Wiley. doi:10.1002/cam4.4635.

Cancer MedicineJournal

A <scp>win</scp> Consortium Phase I Study Exploring Avelumab, Palbociclib, and Axitinib in Advanced Non‐small Cell Lung Cancer

clinicaltrials.govStudy

Survival Prolongation by Rationale Innovative Genomics

2017. "Survival Prolongation by Rationale Innovative Genomics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03386929.