ADXS-503 for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Providence Cancer Institute, Portland, OR
Lung Cancer+5 More
ADXS-503 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat lung cancer.

See full description

Eligible Conditions

  • Lung Cancer
  • Metastatic Non-Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Metastatic Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether ADXS-503 will improve 2 primary outcomes, 4 secondary outcomes, and 3 other outcomes in patients with Lung Cancer. Measurement will happen over the course of 12 Months.

12 Months
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
3 years
Preliminary anti-tumor activity of ADXS-503 alone in Part A and ADXS-503 with Pembrolizumab in Part B
4 years
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 + pembrolizumab in Part C
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.
5 years
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.
Safety/Tolerability of ADXS-503 with pembrolizumab in Part C: graded per comment terminology criteria for adverse events (CTCAE) version 4.03
up to 5 years
Immunological activity of ADXS-503, administered as monotherapy in Part A and in combination with pembrolizumab in Part B.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

3 Treatment Groups

Safety Phase Part A
1 of 3
Efficacy Phase Part C
1 of 3
Safety Phase Part B
1 of 3
Experimental Treatment

This trial requires 74 total participants across 3 different treatment groups

This trial involves 3 different treatments. ADXS-503 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Safety Phase Part A
Drug
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.
Efficacy Phase Part CEnroll 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.
Safety Phase Part BEnroll 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Closest Location

Providence Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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;
Subject has histologically or cytologically confirmed stage IV (metastatic) squamous or non-squamous NSCLC
▪ Subject has received, and then progressed or been intolerant to up to 3 lines of prior therapy in the metastatic setting, including approved chemotherapy, targeted therapy, immunotherapy and antibody therapy, if eligible. Subjects who have received >3 lines of prior therapy may be eligible for Part A, upon discussion with and approval by the Sponsor.
Subjects will be eligible for Part A irrespective of PD-L1 expression.
Subjects will be eligible for Part A irrespective of EGFR or ALK mutation status. However, subjects with an EGFR sensitizing mutation or ALK translocation must have received and then progressed or been intolerant to at least 1 prior line of approved targeted therapy to be eligible for Part A.
Subject is undergoing treatment with pembrolizumab monotherapy for metastatic NSCLC
Subject's most recent tumor assessment is consistent with PD according to RECIST v1.1
The Investigator has determined that PD should be confirmed within 4-8 weeks, and pembrolizumab treatment will continue pending PD confirmation
Subject is willing to undergo a confirmatory scan 4-8 weeks from the prior scan that indicated progression on pembrolizumab

Patient Q&A Section

How many people get carcinoma, non-small-cell lung a year in the United States?

"About 300,000 cases of non-small-cell lung malignancy are diagnosed each year in the United States. Lung cancer is the most common malignant disease in women and men that is diagnosed in the United States." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"Carcinoma, non-small-cell lung was the leading cause of mortality in patients with lung disease in New Zealand in 2008. A decrease in overall mortality was demonstrated in the last 2 decades." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

"There is no single treatment which is optimal for all types of cancers at all times. Therefore, clinical trials and treatment options should be tailored to each individual patient and their disease. However, a few common treatments can be used across cancers. Most commonly, radiotherapy is the treatment of choice in patients with lung cancer. It is effective even in treating TNBCs. It may be combined with other treatment modalities, such as surgery, chemotherapy, and/or biotechnology, depending on the type of cancer and the patient. Moreover, many patients with cancer may benefit from treatment with targeted therapies, such as inhibitors of epidermal growth factor receptor (EGFR) and programmed cell death-1 (PD-1)." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, non-small-cell lung be cured?

"Although there remain unanswered questions concerning the current treatment of carcinoma, non-small-cell lung, and for a number of patients, the current level of evidence may prompt a realistic assessment that this disease may ultimately be curable." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"In people with lung cancer, inactivating mutations in the PTEN, p53, or BRCA1 (BRAF) genes occur very infrequently; other common mutations of lung cancer are TP53 and KRAS mutations. Lung cancer risk is increased in smokers." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, non-small-cell lung?

"Data from a recent study suggests that erythropoietin, an erythropoietin receptor (EPOR) agonist, may be as effective and a more convenient therapeutic agent in the treatment of advanced erythropoietic protoporphyria (EPP) compared to erythropoietin analogues." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, non-small-cell lung?

"Overall, the study results revealed a considerable association between the cigarette smoking, and development of carcinoma, non-small-cell lung. Cigarette smoking, might be a primary cause of carcinoma, non-small-cell lung cancer. It is therefore necessary to discourage the cigarette smoking in general and to educate the young people about smoking and health. It is also of important to emphasize that, tobacco smoking does not provide a complete explanation to cause all lung tumors." - Anonymous Online Contributor

Unverified Answer

Has adxs-503 proven to be more effective than a placebo?

"Adxs-503 may be effective in reducing progression-free survival in advanced and/or metastatic (metastatic) NSCLC subjects with ALK-positive tumors treated with either the platinum-based standard of care chemotherapy or sorafenib, in comparison with a placebo. In fact, significant differences were also observed in progression-free survival from day 3 of treatment onwards." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, non-small-cell lung?

"Patients who were treated with radiation therapy and/or chemotherapy and/or surgery had a significantly better prognosis than those who were treated with chemotherapy or surgical debulking procedures alone." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, non-small-cell lung?

"Survival rates depend on many factors such as size of the primary tumors, presence and extent of lymph node involvement, and presence of metastases to other organs. Survival rate is about 30% at 2 years. The majority of patients, most of whom have stage III or IV disease, will live 1 year or longer. Survival rate will depend almost entirely on the presence of metastases." - Anonymous Online Contributor

Unverified Answer

Is adxs-503 typically used in combination with any other treatments?

"Although the results of our analysis did not demonstrate that the use of ADxs-503 improved survival over the use of any other therapies, it is still an important treatment as part of other chemotherapy regimens of patients with NSCLC." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma, non-small-cell lung?

"The average age of first diagnosis of nonsmoking invasive carcinoma, except for small cell carcinoma, in the current study was 62 years, which is inconsistent with and possibly an underestimate of the true average lifespan of persons with nonsmoking lung carcinoma. To account for this underestimation, the mean longevity of persons with current nonsmoking lung carcinoma may be higher than the mean longevity in the general population. However, a lifetime tobacco exposure risk, if there is high risk for early onset lung carcinoma, seems less likely than with a low nicotine exposure risk, even in those with current lung carcinoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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