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Tremelimumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Taipei, TaiwanNon-Small Cell Lung Cancer+2 MoreTremelimumab - Drug
Eligibility
18 - 110
All Sexes
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Study Summary

This trial is testing a new combination of drugs to treat advanced solid tumors. It will evaluate how well the drugs work and how safe they are.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 7 Secondary · Reporting Duration: From first dose until death due to any cause through study completion, up to 4 years

Day 28
Number of subjects with Dose Limiting Toxicities (DLTs)
Day 90
Number of subjects with Adverse Events (AEs)
Year 4
Overall Survival (OS)
Year 4
Disease-free survival (DFS)
Week 48
Disease control rate (DCR)
Year 4
Duration of response (DoR)
Year 4
Best objective response (BoR)
Objective response rate (ORR)
Year 4
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Relacorilant
1
R/R DLBCL
1
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Side Effects for

Durvalumab and Tremelimumab
38%Fatigue
21%Diarrhea
17%Anorexia
17%Pruritus
17%Maculopapular rash
17%Fever
17%Nausea
14%Constipation
14%Rash maculo-papular
10%Abdominal pain
10%Itching
10%Anemia
7%Cough
7%Dry Skin
7%Non-cardiac chest pain
7%Weight loss
7%Hypothyroidism
7%Dehydration
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03007407) in the Durvalumab and Tremelimumab ARM group. Side effects include: Fatigue with 38%, Diarrhea with 21%, Anorexia with 17%, Pruritus with 17%, Maculopapular rash with 17%.

Trial Design

8 Treatment Groups

NSCLC Arm 2
1 of 8
NSCLC Arm 3
1 of 8
SCLC Arm 1
1 of 8
SCLC Arm 4
1 of 8
HNSCC Arm 1
1 of 8
NSCLC Arm 1
1 of 8
SCLC Arm 2
1 of 8
SCLC Arm 3
1 of 8

Experimental Treatment

105 Total Participants · 8 Treatment Groups

Primary Treatment: Tremelimumab · No Placebo Group · Phase 1

NSCLC Arm 2Experimental Group · 4 Interventions: Paclitaxel, Durvalumab, External beam radiation (dose level 2), Carboplatin (dose level 1) · Intervention Types: Drug, Drug, Radiation, Drug
NSCLC Arm 3Experimental Group · 5 Interventions: Durvalumab, Pemetrexed, External beam radiation (dose level 2), Cisplatin (dose level 2), Carboplatin (dose level 2) · Intervention Types: Drug, Drug, Radiation, Drug, Drug
SCLC Arm 1Experimental Group · 5 Interventions: Durvalumab, Etoposide (dose level 2), External beam radiation (standard), Carboplatin (dose level 2), Cisplatin (dose level 3) · Intervention Types: Drug, Drug, Radiation, Drug, Drug
SCLC Arm 4Experimental Group · 6 Interventions: Durvalumab, Etoposide (dose level 2), External beam radiation (hyperfractionated), Carboplatin (dose level 2), Tremelimumab, Cisplatin (dose level 3) · Intervention Types: Drug, Drug, Radiation, Drug, Drug, Drug
HNSCC Arm 1Experimental Group · 3 Interventions: Durvalumab, External beam radiation (dose level 1), Cisplatin (dose level 4) · Intervention Types: Drug, Radiation, Drug
NSCLC Arm 1Experimental Group · 4 Interventions: Cisplatin (dose level 1), Etoposide (dose level 1), Durvalumab, External beam radiation (dose level 2) · Intervention Types: Drug, Drug, Drug, Radiation
SCLC Arm 2Experimental Group · 5 Interventions: Durvalumab, Etoposide (dose level 2), External beam radiation (hyperfractionated), Carboplatin (dose level 2), Cisplatin (dose level 3) · Intervention Types: Drug, Drug, Radiation, Drug, Drug
SCLC Arm 3Experimental Group · 6 Interventions: Durvalumab, Etoposide (dose level 2), External beam radiation (standard), Carboplatin (dose level 2), Tremelimumab, Cisplatin (dose level 3) · Intervention Types: Drug, Drug, Radiation, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Durvalumab
FDA approved
Pemetrexed
FDA approved
Tremelimumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose until death due to any cause through study completion, up to 4 years

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,021 Previous Clinical Trials
240,381,020 Total Patients Enrolled

Eligibility Criteria

Age 18 - 110 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not taken any immune-based treatments or cancer vaccines in the past.
References

Frequently Asked Questions

Are there any available openings in this medical study for new participants?

"According to the latest data posted on clinicaltrials.gov, this medical trial is not presently searching for participants - it was originally published in May 2018 and last edited in September 2022. Fortunately, there are 6,005 other studies actively seeking individuals at present." - Anonymous Online Contributor

Unverified Answer

How many participants are enrolled in the current clinical trial?

"Recruitment for this trial has been terminated, as the last edit to its listing was made on September 27th 2022. However, there are currently 4061 clinical trials recruiting patients with small cell lung cancer and 1944 studies looking for participants that can be enrolled in a Tremelimumab-related investigation." - Anonymous Online Contributor

Unverified Answer

Could I qualify for participation in this research?

"This clinical trial is aiming to enroll 105 individuals, aged between 18 and 110 years old and diagnosed with small cell lung carcinoma. Furthermore, they must have not had any prior exposure to immunotherapy or therapeutic anticancer vaccines, possess a World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or 1 as well as having at least one detectable lesion that has yet to be irradiated." - Anonymous Online Contributor

Unverified Answer

Does this medical experiment permit individuals over sixty years old to participate?

"This medical study is open to patients aged 18 and over, up until the age of 110." - Anonymous Online Contributor

Unverified Answer

Could you provide me with a summary of the research surrounding Tremelimumab?

"The initial trials of Tremelimumab date back to 1997 at the City of Hope Comprehensive Cancer Center. Since then, 2778 clinical studies have been completed with 1944 still active; a vast majority are based in Tucson, Arizona." - Anonymous Online Contributor

Unverified Answer

What is the chief therapeutic purpose for which Tremelimumab is regularly prescribed?

"Tremelimumab is a reliable treatment option for metastatic ureter urothelial carcinoma, as well as lymphoma, non-hodgkin's disease, merkel cell cancer and locally advanced cases of non-small cell lung cancer." - Anonymous Online Contributor

Unverified Answer

Has Tremelimumab obtained the seal of approval from the United States Food and Drug Administration?

"With limited evidence in support of its efficacy and safety, Tremelimumab has been tentatively assigned a score of 1." - 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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