Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Cisplatin

Durvalumab

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Durvalumab + Investigator's choice of chemotherapy

Durvalumab + Investigator's choice of chemotherapy + danvatirsen

Durvalumab + investigator's choice of chemotherapy + oleclumab

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8

Danvatirsen

Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Oleclumab

MEDI5752

Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study

Carboplatin IV Day 1 of each 21-day cycle

Gemcitabine IV Days 1 and 8 of each 21-day cycle

Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

Nab-paclitaxel

AZD2936

Sandip Patel, MD

Chih-Hsin Yang, MD

This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)

This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC).

Treatment arms for MEDI5752 (Arms A4 and B4) will enroll 42 and 60 patients, respectively. Arm B5 (AZD2936+chemotherapy) will enroll 60 patients.

For all other treatment arms, 30 patients will be enrolled into each arm; additional patients may be enrolled in order to have 30 evaluable patients per arm (ie, dosed).

A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Assessment of safety and tolerability of each treatment arm

Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR or PR

Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response until the date of objective radiological disease progression

Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of treatment assignment until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)

OS: Time from date of treatment assignment until the date of death by any cause

Drug concentration of durvalumab and novel oncology therapies

Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms

AstraZeneca

Antibodies

Antibodies, Bispecific

Immunoglobulins

Rilvegostomig Intravenous (IV) monotherapy

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-D (dose expansion).

The study includes 4 parts: Part A: Dose escalation; B \& C: Dose expansion non-randomized; D: Randomized RP2D \& alternative dose.

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

Percentage of participants with AEs leading to discontinuation of rilvegostomig

Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1

Percentage of participants with a confirmed CR or PR according to RECIST v1.1

Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment

The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression

The percentage of participants according to RECIST v1.1 with a confirmed CR or PR lasting 6 months or more

The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression

Evaluation of the target engagement of rilvegostomig in peripheral blood

Maximum observed plasma concentration of rilvegostomig

Area under the plasma concentration-time curve

A pharmacokinetic measurement of the volume of plasma from which the study intervention is completely removed per unit time.

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Pharmaceutical Solutions

Amino Acids

Immunoglobulin Fab Fragments

Histidine

Dose formulation- AZD2936 is supplied as a liquid drug product in a 20R vial containing 750 mg (nominal) of active AZD2936. The solution contains 50 mg/mL AZD2936 in 20 mM L-histidine/L- histidine-hydrochloride, 240 mM sucrose, 0.04% (w/v) poloxamer 188, at pH 6.0.

Unit dose strength(s)- 750 mg/vial (50 mg/mL) Dosage levels- 750mg administered Q3W Route of administration- IV infusion over 1 hour

AZD2936 is a monovalent, bispecific, humanized, IgG1 triple mutant mAb antibody against human PD 1 and TIGIT. AZD2936 was constructed on the backbone of the DuetMab molecule (Mazor et al., 2015), and its antigen binding fragment portions are comprised of the variable domains of the anti TIGIT COM902 antibody and anti PD 1 LO115 antibody. The IgG1 Fc domain carries the triple mutation (L234F/L235E/P331S) designed to reduce Fc mediated immune effector functions. In the preclinical studies, dual blockade of TIGIT and PD 1 by AZD2936 enhanced human T cell function and promoted antitumor immune responses.

Lillian Siu, MD

Minge Xu

This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment. Approximately 200 patients are expected to be enrolled.

This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment. Approximately 200 patients are expected to be enrolled.

The study is divided in 5 parts:

Part A and Part B are common for all patients in the study, which are defined as the periods of definitive treatment and post definitive treatment. Definitive treatment will be either surgery followed by radiation or chemoradiation; definitive radiation or definitive chemoradiation according to standard of care (SOC) in our institution. A baseline ctDNA sample collection and CT staging will be done before treatment. ctDNA analysis will be performed in Part B at approximately week 5 and at week 10 of this period, and patients will be classified as MRD positive or MRD negative based on the week 10 results. If a patient has equivocal results, a new sample will be taken around week 14. Patients who receive surgery as part of their treatment, will also get ctDNA analysis post-surgery.

Part C is the randomized and interventional part of the study (n=60) for patients with MRD. The patient will be randomized 3:1 to Arm A (treatment with AZD2936) or Arm B (observation). Patients in Arm A will continue treatment until the occurrence of any of these circumstances: after completion of 6 cycles, intolerable toxicity or patient decision. ctDNA analysis will be done at week 10 of Part C.

Part D is the follow up part for patients with MRD. Two ctDNA samples will be analyzed at week 2 and at week 10 of Part D. Plasma samples will be collected every 6 months for the first 3 years and a final sample will be also collected if the patient has radiological or clinical progression. A CT/MRI scan will be performed at week 2 of Part D and, if clinically needed, according to SOC.

Part E is the observational follow up part for patients without MRD. A ctDNA sample will be collected at the time of the first follow up and at radiological or clinical progression if applicable.

Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

• Changes in HPV DNA in MRD+ HPV+ patients treated with AZD2936 or under observation and correlation of such changes with DFS.

Changes in methylated ctDNA in MRD+ patients treated with AZD2936 or under observation, and correlation of such changes with bespoke ctDNA and with DFS.

Changes in quantitative bespoke ctDNA and HPV DNA measurements before treatment and at W4-6 and W 8-12 (Parts A and B).

Changes in quantitative bespoke ctDNA and HPV DNA measurements during and after treatment/observation (Parts C and D).

Correlation between radiological response and changes in quantitative bespoke ctDNA and HPV DNA measurements.

• Compare DFS in patients with detectable ctDNA after surgery versus those patients with no detectable ctDNA.

Compare DFS in the MRD-negative observational cohort with DFS in the MRD+ patients under observation (Arm B in Part C).

Overall mean changes in FACT-ICM and EORTC HN43 scores in MRD+ LA-HNSCC patients from baseline (of Part C) and cross sectional comparisons including during and after AZD2936/observation and at progression.

Overall mean changes in and EORTC HN43 scores in MRD+ LA-HNSCC patients from baseline (of Part A) and cross sectional comparisons including before, during and after AZD2936/observation and at progression

-Overall mean changes in EORTC HN43 scores in MRD-negative LA-HNSCC patients from baseline (part A) and cross sectional comparisons including first year post definitive treatment and at progression.

• Incremental cost effectiveness ratios (ICERs)

Clearance of bespoke ctDNA at different time points (week 2 and week 10 after the end of MRD treatment). ctDNA clearance is defined as no detection of ctDNA in both of these two consecutive determinations.

Disease free survival (DFS) at 12 months.

Time to MRD control failure in MRD+ patients. MRD control failure is defined as two consecutive increases in ctDNA levels (week 2 and week 10 in Part D).

* Number and severity of treatment related adverse events according to CTCAE v5.0.
* Percentage of participants with AEs, SAEs and rate of AZD2936 discontinuation due to toxicity.

NeoGenomics Laboratories

University Health Network, Toronto

Immunomodulating Agents

Datopotamab deruxtecan (Dato-DXd) + Durvalumab in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy

Datopotamab deruxtecan (Dato-DXd) + Durvalumab + Carboplatin in NSCLC participants who are either treatment-naïve or have received only 1 prior line of systemic chemotherapy without concomitant ICI therapy

Datopotamab deruxtecan (Dato-DXd) + AZD2936 in participants with treatment-naïve NSCLC

Datopotamab deruxtecan (Dato-DXd) + AZD2936 + Carboplatin in participants with treatment-naïve NSCLC

Datopotamab deruxtecan (Dato-DXd) + MEDI5752 + Carboplatin in participants with treatment-naïve NSCLC

Datopotamab deruxtecan (Dato-DXd) + MEDI5752 in participants with treatment-naïve NSCLC

Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with CPI acquired resistant NSCLC

Datopotamab deruxtecan (Dato-DXd) + AZD7789 in participants with treatment-naïve NSCLC

Intravenous infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle

Datopotamab deruxtecan

Intravenous infusion Q3W on Day 1 or Day 2 of each 21-day cycle

AZD7789

AstraZeneca Clinical Study Information Center

This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

The primary objective is to assess the safety and tolerability of Dato-DXd in combination with immunotherapy with or without 4 cycles of carboplatin in participants with advanced or metastatic NSCLC.

Two dose levels of Dato-DXd will be studied in combination with immunotherapy (durvalumab, AZD2936, MEDI5752, or AZD7789) with or without 4 cycles of carboplatin in 14 study cohorts

Each cohort will start with Part 1 (dose escalation or confirmation), where 3 to 9 participants will be assessed for dose-limiting toxicities (DLT) in the first cycle of treatment. if the DLT incidence rate meets the criteria based on the modified toxicity probability interval-2 (mTPI-2), then Part 2 (dose expansion) may be opened.

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

DLTs, TEAEs, SAEs, AESIs, ECOG PS, vital sign measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings

ORR is defined as the proportion of participants with measurable disease at baseline who achieved a BOR of confirmed CR or confirmed PR.

Duration of Response is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of objective PD, or death due to any cause, whichever occurs first.

Disease Control Rate is defined as the proportion of participants who achieved a Best Overall Response of confirmed complete response, confirmed partial response, or stable disease.

Progression-free Survival is defined as the time interval from the date of the start of study treatment to the earlier of the dates of the first documentation of objective PD or death due to any cause, whichever occurs first

Time to Response is defined as the time from the date of the start of study treatment to the date of the first documentation of objective response (confirmed complete response or confirmed partial response)

The best percentage change in the Sum of Diameters of measurable tumors is defined as the percentage change in the smallest Sum of Diameters from all postbaseline tumor assessments, taking as reference the baseline Sum of Diameters.

Overall Survival is defined as the time from the date of the start of study treatment to the date of death due to any cause

Tmax = time to reach maximum concentration.

Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed.

ADA prevalence is defined as the proportion of all participants having ADA at any point in time (including pre-existing ADA at baseline and treatment-emergent ADA)

ADA incidence is defined as the proportion of participants having treatment-emergent ADA during the study period

Daiichi Sankyo

Digestive System Diseases

Rare Diseases

Carcinoma, Hepatocellular

Biliary Tract Neoplasms

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Biliary Tract Diseases

Biliary Tract Cancer

Bevacizumab

Lenvatinib

Adjuvants, Immunologic

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Rilvegostomig combination with Gemcitabine and Cisplatin

Volrustomig combination with Gemcitabine and Cisplatin

Volrustomig combination with rilvegostomig and bevacizumab

Rilvegostomig combination with bevacizumab

Volrustomig

15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

Rilvegostomig

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).

This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.

In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 60 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.

Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)

Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.

PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)

DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression, whichever occurs first.

DCR at 12 and 24 weeks is defined as the percentage of participants who have a Complete response (CR) or Partial response (PR) in the first 13 and 25 weeks or who have Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.

PFS is defined as the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first.

OS is defined as the time from the start of study intervention until the date of death due to any cause, whichever occurs first.

Incidences of ADAs against novel immunomodulators in serum.

Maximum observed plasma concentration of the study drug

Time to maximum observed plasma concentration of the study drug

The number and percentage of participants who develop ADAs.

ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC	NCT03819465	Metastatic Non-...	Durvalumab Danvatirsen Oleclumab MEDI5752 Pemetrexed Carboplatin Gemcitabine Cisplatin Nab-paclitaxel AZD2936	18 Years - 130 Years	AstraZeneca
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC	NCT04995523	Non-Small-Cell ...	AZD2936	18 Years - 130 Years	AstraZeneca
Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC	NCT05414032	Locoregionally ...	AZD2936	18 Years -	University Health Network, Toronto
Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer	NCT04612751	Advanced or Met...	Datopotamab der... Durvalumab Carboplatin AZD2936 MEDI5752 AZD7789	18 Years -	AstraZeneca
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer	NCT05775159	Hepatocellular ... Biliary Tract C...	Volrustomig Bevacizumab Lenvatinib Rilvegostomig Gemcitabine Cisplatin	18 Years -	AstraZeneca
Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer	NCT04612751	Advanced or Met...	Datopotamab der... Durvalumab Carboplatin AZD2936 MEDI5752 AZD7789	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for azd2936

Every month we try and update this database with for azd2936 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd2936

Every month we try and update this database with for azd2936 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd2936 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.