AZD2936 for Non-Small Cell Lung Cancer

(ARTEMIDE-01 Trial)

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AstraZeneca

Must not be taking: Chemotherapy, Radiotherapy, Biologic, Hormonal

Disqualifiers: EGFR mutations, ALK fusion, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine that helps the immune system fight severe lung cancer by stopping the cancer from hiding. It is aimed at adults with advanced lung cancer that cannot be removed by surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment while participating in the trial.

What data supports the effectiveness of the drug AZD2936 for treating non-small cell lung cancer?

Research on similar drugs like ZD1839 shows they can help improve symptoms and quality of life in patients with advanced non-small cell lung cancer by targeting specific molecular processes involved in cancer growth. Additionally, AZD2171, another related drug, has shown broad antitumor activity in preclinical models, suggesting potential effectiveness in treating this type of cancer. ^{1 2 3 4 5}

What safety data exists for AZD2936 or similar treatments in humans?

ZD1839, a similar treatment, showed manageable side effects like skin rash, nausea, vomiting, and diarrhea in early studies, with good tolerance in healthy volunteers. AZD9291, another related treatment, has been associated with rare but serious lung disease in some cases. ^{1 4 6 7 8}

Research Team

Eligibility Criteria

Adults with advanced or metastatic non-small cell lung cancer (NSCLC) that can't be removed by surgery or cured with radiation, and who have seen their cancer progress after treatment. They must not have certain genetic mutations treatable by other drugs, no recent serious blood clots, no other cancers in the last 2 years, and no previous anti-TIGIT therapy.

Inclusion Criteria

Your PD-L1 levels have been tested and reported by your local laboratory.

I am fully active or restricted in physically strenuous activity but can do light work.

My stage IV lung cancer cannot be cured with surgery or radiation.

Exclusion Criteria

My cancer has a specific genetic change that can be treated with targeted therapy.

I have not had any other cancer besides this one in the last 2 years.

I have not had a blood clot in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive rilvegostomig IV monotherapy to determine the maximum tolerated dose

6 months

Regular visits at predefined intervals

Dose Expansion

Participants receive rilvegostomig IV monotherapy to further evaluate safety and efficacy

Approximately 2 years

Regular visits at predefined intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after the last dose

Treatment Details

Interventions

• AZD2936 (Monoclonal Antibodies)

Trial Overview The trial is testing AZD2936, a new bispecific antibody targeting two immune checkpoints: TIGIT and PD-1. It's for people whose NSCLC has worsened despite current treatments. The study aims to find out if this drug is safe and effective at controlling their cancer.

Participant Groups

Group I: Dose Expansion Part E: treatment Naive Squamous NSCLC Experimental Treatment 1 Intervention

Rilvegostomig IV monotherapy

Group II: Dose Expansion Part D: CPI Naive NSCLC Experimental Treatment 1 Intervention

Rilvegostomig IV monotherapy

Group III: Dose Expansion Part C: CPI Naive NSCLC Experimental Treatment 1 Intervention

Rilvegostomig IV monotherapy

Group IV: Dose Expansion Part B: CPI experienced NSCLC Experimental Treatment 1 Intervention

Rilvegostomig IV monotherapy

Group V: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC) Experimental Treatment 1 Intervention

Rilvegostomig Intravenous (IV) monotherapy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Chicago, IL

Research Site Rochester, MN

Research Site Fairfax, VA

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4491

Patients Recruited

290,540,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical observation of ZD1839 in treating 32 cases of non-small-cell lung cancer]. Zhang, L.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway-Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Aggarwal, C., Redman, MW., Lara, PN., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of epidermal growth factor receptor and symptom improvement in advanced non-small cell lung cancer. Natale, RB.[2005]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ZD 1839 in patients with brain metastases from non-small-cell lung cancer (NSCLC): report of four cases. Cappuzzo, F., Calandri, C., Bartolini, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: the National Cancer Institute of Canada clinical trials group. Laurie, SA., Gauthier, I., Arnold, A., et al.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatal interstitial lung disease associated with AZD9291. Deng, SM., Huang, JA., Chen, YB.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Zd 1839 "Iressa"]. Meric, JB., Faivre, S., Monnerat, C., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A natural anthraquinone derivative shikonin synergizes with AZD9291 against wtEGFR NSCLC cells through reactive oxygen species-mediated endoplasmic reticulum stress. Hu, X., Zhang, ZY., Wu, LW., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

[Clinical observation of ZD1839 in treating 32 cases of non-small-cell lung cancer]. [2018]

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

SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway-Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). [2022]

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

Inhibition of epidermal growth factor receptor and symptom improvement in advanced non-small cell lung cancer. [2005]

4. England pubmed.ncbi.nlm.nih.gov

ZD 1839 in patients with brain metastases from non-small-cell lung cancer (NSCLC): report of four cases. [2023]

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

Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: the National Cancer Institute of Canada clinical trials group. [2015]

6. India pubmed.ncbi.nlm.nih.gov

Fatal interstitial lung disease associated with AZD9291. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Zd 1839 "Iressa"]. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

A natural anthraquinone derivative shikonin synergizes with AZD9291 against wtEGFR NSCLC cells through reactive oxygen species-mediated endoplasmic reticulum stress. [2022]