Quick Start Durvalumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Lycan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Wake Forest University Health Sciences

Must be taking: Platinum chemotherapy

Must not be taking: Tyrosine kinase inhibitors

Disqualifiers: Autoimmune disease, Congestive heart failure, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study aims to determine what effects (good and bad) Durvalumab has on participants and their cancer with a "quick start" of Durvalumab within 14 days of finishing chemotherapy and radiation. The study will also determine the logistic barriers to the quick start of Durvalumab.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Durvalumab for lung cancer?

Durvalumab has shown to improve survival rates and delay disease progression in patients with stage III non-small cell lung cancer, especially after chemoradiotherapy, according to the PACIFIC trial. It has also demonstrated promising results in increasing progression-free survival and response rates in advanced lung cancer patients. ^{1 2 3 4 5}

Is durvalumab safe for humans?

Durvalumab has been shown to have a manageable safety profile in treating various cancers, but it can cause immune-related side effects, such as pneumonitis (lung inflammation), which can be serious. In a study for lung cancer, about 25% of patients experienced immune-related side effects, with only a small percentage having severe reactions. ^{1 3 6 7 8}

What makes the drug durvalumab unique for lung cancer treatment?

Durvalumab is unique because it is a monoclonal antibody that blocks PD-L1, enhancing the immune system's ability to fight cancer cells. It has shown impressive results in increasing progression-free survival in patients with inoperable and locally advanced stage III non-small cell lung cancer, especially after chemoradiation. ^{1 2 3 4 9}

Research Team

Thomas Lycan

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with Stage III non-small cell lung cancer who've recently completed or are completing chemoradiation. They must have a life expectancy over three months, be able to use contraception if necessary, and sign informed consent. Excluded are those with uncontrolled symptoms, cancer progression during radiation, active autoimmune diseases requiring steroids, pregnancy/breastfeeding, certain heart conditions or mental illnesses affecting study compliance.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

My condition cannot be treated with surgery.

I am 18 years old or older.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I have had severe lung inflammation treated with high-dose steroids.

Patients who are pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants undergo chemotherapy and radiation therapy for Stage III nonsmall cell lung cancer

Varies

Treatment

Quick start of Durvalumab within 14 days of finishing chemoradiation

48 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Durvalumab (PD-L1 Inhibitor)

Trial Overview The trial tests the effects of Durvalumab given within 14 days after finishing chemotherapy and radiation ('quick start'). It examines both positive and negative outcomes on patients' health and identifies logistical challenges in starting treatment promptly.

Participant Groups

Group I: Quick Start Durvalumab Experimental Treatment 4 Interventions

Standard of care test and procedures for cancer treatments along with Durvalumab treatment at physician's discretion

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

🇺🇸 Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

🇯🇵 Approved in Japan as Imfinzi for:

• Not specified in provided sources

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1432

Patients Recruited

2,506,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. Yang, H., Shen, K., Zhu, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab: First Global Approval. Syed, YY.[2022]

Durvalumab, a PD-L1 blocking antibody, has shown clinical efficacy and a manageable safety profile in treating advanced non-small-cell lung cancer, especially in patients with ≥25% PD-L1 expression.

The drug is being evaluated in various treatment settings, including as a monotherapy and in combination with other therapies, showing promising results particularly after chemoradiation, although lower response rates were noted in patients with EGFR and ALK mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab in non-small-cell lung cancer patients: current developments. Mezquita, L., Planchard, D.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durvalumab Promising for NSCLC. [2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. Spigel, DR., Faivre-Finn, C., Gray, JE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Naidoo, J., Vansteenkiste, JF., Faivre-Finn, C., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Incidence of Pneumonitis in Patients Receiving Durvalumab. LeClair, JN., Merl, MY., Cohenuram, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Voss, MH., Azad, AA., Hansen, AR., et al.[2023]

In a study of 81 patients with unresectable locally advanced non-small cell lung cancer (NSCLC), those with high tumor mutational burden (TMB-high) showed significantly better outcomes, including lower local-regional failure rates (9% vs 51%) and improved progression-free survival (66% vs 27%) compared to TMB-low patients.

The study suggests that TMB status could be a valuable biomarker for personalizing treatment strategies, as it was the only factor significantly associated with local-regional failure and progression-free survival after treatment with chemoradiation and adjuvant durvalumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Tumor Mutational Burden, Progression-Free Survival, and Local-Regional Control in Patents with Locally Advanced Non-Small Cell Lung Cancer Treated With Chemoradiation and Durvalumab. Lebow, ES., Shepherd, A., Eichholz, JE., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Durvalumab: First Global Approval. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Durvalumab in non-small-cell lung cancer patients: current developments. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Durvalumab Promising for NSCLC. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Real-World Incidence of Pneumonitis in Patients Receiving Durvalumab. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Analysis of Tumor Mutational Burden, Progression-Free Survival, and Local-Regional Control in Patents with Locally Advanced Non-Small Cell Lung Cancer Treated With Chemoradiation and Durvalumab. [2023]