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CAR T-cell Therapy

ADXS-503 for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Advaxis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject and/or their legally authorized representative must be capable of understanding the investigational nature, potential risks, and benefits of the study. The subject and/or their legally authorized representative must sign a written informed consent;
Subject is ≥18 years of age upon signing the Informed Consent Form;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment, ADXS-503, alone and in combination with another cancer treatment, pembrolizumab, in people with metastatic squamous or non-squamous non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Non-Squamous Carcinoma
  • Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You or your legal representative must understand what the study involves, including its possible risks and benefits. You must sign a document, called an informed consent, to show that you agree to participate.
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You must be 18 years old or older when you sign the consent form.
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You have been diagnosed with advanced stage lung cancer that has spread to other parts of your body.
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You have received up to three different types of treatments for your cancer that have not worked or caused severe side effects. If you have received more than three treatments, you may still be eligible with the approval of the study sponsor.
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PD-L1 expression is not a requirement for participation in Part A.
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You can participate in Part A of the study regardless of your genetic mutation status. However, if you have a specific mutation in your EGFR or ALK genes, you must have already received and not responded well to at least one approved targeted therapy to be eligible for Part A.
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You are currently receiving only pembrolizumab as a treatment for your advanced non-small cell lung cancer.
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Your most recent tumor assessment shows that the disease has progressed according to the RECIST v1.1 criteria.
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The doctor needs to confirm if the treatment is working within 4-8 weeks. If it's not working, pembrolizumab treatment will stop.
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You need to have another scan to confirm that the treatment is not working, 4-8 weeks after your last scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Preliminary anti-tumor activity of ADXS-503 + pembrolizumab in Part C
Safety/Tolerability of ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B: graded per comment terminology criteria for adverse events (CTCAE) version 4.03
Secondary outcome measures
Overall survival (OS) and OS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C
Preliminary anti-tumor activity of ADXS-503 alone in Part A and ADXS-503 with Pembrolizumab in Part B
Progression-free survival (PFS) and PFS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C.
+1 more
Other outcome measures
Immunological activity of ADXS-503, administered as monotherapy in Part A and in combination with pembrolizumab in Part B.
Preliminary anti-tumor activity of ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C
Progression-free survival (PFS) and PFS rate per iRECIST for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C.

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: Safety Phase Part BExperimental Treatment2 Interventions
Enroll subjects with metastatic squamous or non-squamous NSCLC. ADXS-503 will be evaluated at 2 planned escalating dose levels in combination with a fixed dose of pembrolizumab: Dose level 1: 1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met. Dose level 2: 5e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
Group II: Safety Phase Part AExperimental Treatment1 Intervention
Enroll subjects with metastatic squamous or non-squamous NSCLC who have become refractory or intolerant to standard therapy. ADXS-503 monotherapy will be evaluated at 2 planned escalating dose levels: Dose level 1: 1e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met. Dose level 2: 5e8 CFU of ADXS-503, IV, every 3 weeks until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
Group III: Efficacy Phase Part CExperimental Treatment2 Interventions
Enroll subjects with metastatic squamous or non-squamous NSCLC. 1e8 CFU of ADXS-503 + 200 mg of pembrolizumab, IV, every 3 weeks for up to 2 years or until disease progression, unacceptable toxicity, or another treatment discontinuation criterion is met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Advaxis, Inc.Lead Sponsor
12 Previous Clinical Trials
473 Total Patients Enrolled
Surya VangalaStudy DirectorSenior Director, Clinical Operations, Advaxis Inc

Frequently Asked Questions

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

How many healthcare facilities are currently administering this trial?

"Nine healthcare centres are collaborating on this clinical trial, such as Atlantic Health System, the Carol G Simon Cancer Center in Morristown and Virginia Cancer Specialists in Fairfax. In addition to these 3 sites there are 6 other locations conducting trials including Providence Cancer Institute in Portland."

Answered by AI

How many participants are currently involved in this clinical research?

"To facilitate the trial's progress, 74 qualified participants are needed. The sponsor of this research is Advaxis, Inc., and it will be conducted in various locations such as Atlantic Health System, Carol G Simon Cancer Center located in Morristown (NJ) and Virginia Cancer Specialists based on Fairfax (VA)."

Answered by AI

To what ailments is ADXS-503 typically prescribed?

"ADXS-503 has been approved for usage in treating malignant neoplasms and can also be used to address the challenges posed by unresectable melanoma, microsatellite instability high, or a lack of response from chemotherapy."

Answered by AI

What prior investigations have been conducted on ADXS-503?

"ADXS-503 was initially studied at City of Hope in the year 2010. Currently, there are 251 completed studies and 961 ongoing investigations, with a number of them located in Morristown, New jersey."

Answered by AI

Is enrollment currently being offered for this research project?

"Affirmative. The clinical trial details hosted on clinicaltrials.gov indicate that the experiment, which was initially posted in February of 2019, requires 74 participants from 9 separate centres and is currently seeking out candidates."

Answered by AI

What outcomes is this trial seeking to accomplish?

"This 4-year trial aims to evaluate the Saftey/Tolerability of ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B according to CTCAE termionology criteria. Secondary objectives involve measuring preliminary anti-tumor activity, overall survival (OS) rates for subjects treated with either drug alone or both drugs together, as well as safety measures such as adverse events and dose limiting toxicities graded per CTCAE version 4.03."

Answered by AI
~12 spots leftby Mar 2025