51 Participants Needed

Local Consolidative Therapy + Durvalumab for Lung Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial finds out the effect of local consolidative therapy and durvalumab in treating patients with stage III non-small cell lung cancer that has 3 or fewer lesions of progression (oligoprogressive) and greater than 3 lesions of progression (polyprogressive) after chemoradiation and anti-PD-l1 therapy. Local consolidative therapy, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving local consolidative therapy and durvalumab may help to control the disease.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there is a 28-day washout period (time without taking certain medications) required for most anticancer therapies before starting the study drug, except for durvalumab. It's best to discuss your specific medications with the study team.

Is durvalumab (Imfinzi) safe for humans?

Durvalumab (also known as Imfinzi or MEDI4736) has been shown to have manageable safety in patients with non-small cell lung cancer (NSCLC) after chemoradiotherapy, with adverse events documented in clinical studies. It is generally considered to have acceptable tolerability, although treatment-related side effects are an important consideration.12345

What makes the drug Durvalumab unique for lung cancer treatment?

Durvalumab is unique because it is an immunotherapy drug that boosts the immune system to fight cancer by blocking a protein called PD-L1, and it is used after chemoradiotherapy to improve survival in patients with locally advanced non-small cell lung cancer.678910

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

Research shows that adding Durvalumab to chemoradiation improves survival and disease control in patients with locally advanced non-small cell lung cancer. The PACIFIC trial demonstrated significant improvements in overall survival and progression-free survival with Durvalumab compared to a placebo.146911

Who Is on the Research Team?

JY

Joe Y Chang, MD,MS,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with stage III non-small cell lung cancer who've had chemoradiation and anti-PD-L1 therapy but still have up to 3 progressing lesions (oligoprogressive) or more than 3 (polyprogressive). They should be fit for radiation, have a life expectancy of at least 12 weeks, and their major organs must function within certain limits. People with certain genetic mutations or unresolved severe side effects from previous treatments can't join.

Inclusion Criteria

I have stage III lung cancer, treated with chemoradiation and durvalumab, but my cancer either worsened or didn't fully respond.
You are expected to live for at least 12 more weeks.
My cancer has spread, but only to 3 or fewer places.
See 13 more

Exclusion Criteria

I haven't had any live vaccines in the last 30 days.
I have had cancer before, but it was a different type.
I have or had an autoimmune or inflammatory disorder.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Local Consolidative Therapy (LCT)

Patients undergo LCT consisting of radiation therapy and/or surgery

4 weeks
1 visit (in-person)

Treatment

Patients receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

28 days per cycle
1 visit per cycle (in-person)

Chemotherapy (Cohort B only)

Patients receive chemotherapy options such as carboplatin and paclitaxel, carboplatin and nab-paclitaxel, or carboplatin and gemcitabine. Treatment repeats every 21 days for 4 cycles

12 weeks
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 12 weeks for 2 years
1 visit every 12 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Local Consolidation Therapy
Trial Overview The trial tests if adding local consolidative therapy (like surgery/radiation) to durvalumab immunotherapy helps control the disease better in patients whose cancer has progressed after initial treatments. It aims to see if this combination can kill remaining tumor cells and boost the immune system's ability to fight cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort B (polyprogressive)Experimental Treatment9 Interventions
Group II: Cohort A (oligoprogressive)Experimental Treatment4 Interventions

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

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Approved in European Union as Imfinzi for:
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Approved in United States as Imfinzi for:
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Approved in Japan as Imfinzi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Published Research Related to This Trial

Durvalumab, a PD-L1 inhibitor, has been shown to be safe for patients with various solid tumors, with common side effects including pruritus and fatigue, based on a meta-analysis of 17 studies involving 1,529 patients.
Higher levels of PD-L1 expression in tumors are linked to better treatment responses to durvalumab, indicating that PD-L1 could serve as a useful biomarker for predicting the drug's efficacy.
Safety and efficacy of durvalumab (MEDI4736) in various solid tumors.Yang, H., Shen, K., Zhu, C., et al.[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 โ‰ฅ25% 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.
Durvalumab in non-small-cell lung cancer patients: current developments.Mezquita, L., Planchard, D.[2018]
In a study of 34 patients with locally advanced non-small cell lung cancer (LA-NSCLC) treated with chemoradiotherapy followed by durvalumab, 26.5% experienced symptomatic pneumonitis, but this did not negatively affect their overall survival or progression-free survival.
The management of pneumonitis included steroid treatment, and 70% of patients were able to safely resume durvalumab after recovery, indicating that re-challenging with durvalumab is feasible even after pneumonitis occurs.
Implications of pneumonitis after chemoradiation and durvalumab for locally advanced non-small cell lung cancer.Hassanzadeh, C., Sita, T., Savoor, R., et al.[2022]

Citations

Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. [2022]
Durvalumab in non-small-cell lung cancer patients: current developments. [2018]
Implications of pneumonitis after chemoradiation and durvalumab for locally advanced non-small cell lung cancer. [2022]
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]
Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. [2022]
Consolidation Immunotherapy After Platinum-Based Chemoradiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer-Cross-Sectional Study of Eligibility and Administration Rates. [2022]
Durvalumab for the treatment of non-small cell lung cancer. [2019]
Durvalumab after definitive chemoradiotherapy in locally advanced NSCLC: Data of the German EAP. [2020]
Nationwide Real-Life Safety and Treatment Exposure Data on Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III, Locally Advanced, Non-small Cell Lung Cancer: Analysis of Patients Enrolled in the French Early Access Program. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Association of Driver Oncogene Variations With Outcomes in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Chemoradiation and Consolidative Durvalumab. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Pneumonitis During Durvalumab Consolidation Therapy Affects Survival in Stage III NSCLC. [2023]
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