Last Updated: June 27, 2026

CLINICAL TRIALS PROFILE FOR IMFINZI


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All Clinical Trials for IMFINZI

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01993810 ↗ Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer Recruiting National Cancer Institute (NCI) Phase 3 2014-02-03 This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.
NCT01993810 ↗ Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer Recruiting NRG Oncology Phase 3 2014-02-03 This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.
NCT01993810 ↗ Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer Recruiting Radiation Therapy Oncology Group Phase 3 2014-02-03 This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.
NCT02154490 ↗ Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer Active, not recruiting National Cancer Institute (NCI) 2014-06-16 This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IMFINZI

Condition Name

Condition Name for IMFINZI
Intervention Trials
Stage III Lung Cancer AJCC v8 8
Stage IIIB Lung Cancer AJCC v8 8
Stage IIIA Lung Cancer AJCC v8 8
Hepatocellular Carcinoma 7
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Condition MeSH

Condition MeSH for IMFINZI
Intervention Trials
Lung Neoplasms 40
Carcinoma 36
Carcinoma, Non-Small-Cell Lung 33
Adenocarcinoma 14
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Clinical Trial Locations for IMFINZI

Trials by Country

Trials by Country for IMFINZI
Location Trials
United States 527
Canada 26
Australia 14
Italy 9
Netherlands 7
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Trials by US State

Trials by US State for IMFINZI
Location Trials
Texas 30
California 24
Illinois 22
New York 18
Missouri 17
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Clinical Trial Progress for IMFINZI

Clinical Trial Phase

Clinical Trial Phase for IMFINZI
Clinical Trial Phase Trials
PHASE1 1
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for IMFINZI
Clinical Trial Phase Trials
Recruiting 65
Not yet recruiting 29
Active, not recruiting 17
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Clinical Trial Sponsors for IMFINZI

Sponsor Name

Sponsor Name for IMFINZI
Sponsor Trials
AstraZeneca 56
National Cancer Institute (NCI) 33
M.D. Anderson Cancer Center 8
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Sponsor Type

Sponsor Type for IMFINZI
Sponsor Trials
Other 136
Industry 79
NIH 34
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Last updated: May 10, 2026

IMFINZI (durvalumab): Clinical Trials Update, Market Analysis, and 2030 Projection

What is IMFINZI and where is it positioned today?

IMFINZI is durvalumab, a programmed death ligand 1 (PD-L1) inhibitor by AstraZeneca used across multiple oncology settings, including locally advanced non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (ES-SCLC), and multiple other solid tumor programs. Its current commercial footprint is anchored by immuno-oncology (IO) front-line and peri-definitive treatment strategies, with ongoing expansion efforts through combination regimens and earlier lines.


Clinical trials update: What phase and readouts are most consequential?

Which IMFINZI trials currently drive the next commercialization step?

The most business-relevant pipeline updates for IMFINZI fall into three buckets: (1) lung cancer expansions (NSCLC and SCLC), (2) consolidation and peri-treatment strategies, and (3) next-wave combinations targeting resistance and broadening eligibility.

1) NSCLC: peri-definitive and post-CRT consolidation

  • PACIFIC-family durability and subgroup expansion remain the base case for IO consolidation in unresectable Stage III NSCLC after concurrent chemoradiation (CRT).
  • The key question for near-term incremental value is uptake expansion by:
    • PD-L1 subgroup applicability
    • staging refinements and real-world treatability
    • competitor-driven indication-specific shifts in clinical practice

Commercial relevance: durable data and subgroup sensitivity influence formulary access and clinician confidence, which drive share more than incremental response metrics alone.

2) SCLC: first-line combination and sequencing

  • IMFINZI plus chemotherapy remains a focal strategy for ES-SCLC, competing against other IO backbones and chemo-IO standards.
  • The market shift in SCLC is dominated by regimen sequencing and tolerability. Small changes in adverse event profiles, dose intensity, and discontinuation rates tend to matter more than marginal response differences.

Commercial relevance: in SCLC, regimen practicality affects adoption across payers and community sites.

3) Solid tumor diversification

IMFINZI’s broader portfolio is organized around combinations and biomarker strategies that can expand beyond lung cancer. These programs tend to be value-add if they establish:

  • a new line of therapy with clear superiority in clinically meaningful endpoints
  • a biomarker-stratified approach that aligns with test availability and payer criteria

Commercial relevance: breadth creates risk buffering if lung indications face competitive pressure.


What are the latest high-signal trial themes to monitor?

Across IMFINZI’s ongoing studies, the highest-signal themes for market impact are:

  1. Earlier-line positioning

    • Trials that move durvalumab into first-line settings or peri-CRT windows tend to create larger addressable populations.
  2. Combination optimization

    • Outcomes hinge on selection of partner therapy, dose schedules, and management of immune-related adverse events (irAEs).
  3. Biomarker practicality

    • Programs that rely on biomarkers that are already routine in oncology care accelerate adoption.

Market analysis: Where does IMFINZI win, and what is pressuring share?

How big is the market opportunity by current indication footprint?

IMFINZI’s addressable market is dominated by:

  • Unresectable Stage III NSCLC post-CRT consolidation
  • ES-SCLC in combination regimens
  • Other solid tumor programs in development or limited-to-approval use

Commercially, the durability of a consolidation indication creates “habit” among clinicians, which slows payer pushback unless competing regimens show strong survival advantages, superior safety, or better cost-effectiveness.


What competitive dynamics matter most?

IMFINZI competes within crowded PD-1/PD-L1 landscapes and within-line treatment standards. The competitive pressures differ by setting:

NSCLC (Stage III consolidation)

  • The main pressure comes from competitor PD-1/PD-L1 inhibitors and alternative post-CRT strategies.
  • Adoption is tied to:
    • perceived survival benefit magnitude versus alternatives
    • toxicity management and patient selection
    • payer policies that enforce biomarker or regimen criteria

ES-SCLC

  • Competition centers on:
    • chemo-IO backbone selection
    • sequencing after response or progression
    • toxicity tolerability in frail populations

What commercial risks could compress growth?

Key risks for IMFINZI’s forecast are structural, not just clinical:

  1. Indication cannibalization

    • If competitors enter peri-CRT or consolidation slots with superior outcomes, IMFINZI growth can plateau even without safety disadvantages.
  2. Price and access

    • Biosimilar risk is not an immediate factor for antibody brands in most geographies, but managed entry agreements, contracting pressure, and indication-specific discounting can compress net sales growth.
  3. Clinical practice drift

    • In SCLC especially, practice can move quickly when a regimen becomes “default” through ease of use, cost, or trial credibility.

2030 projection: What does the growth path likely look like?

What drives the IMFINZI revenue curve through 2030?

The revenue trajectory for an oncology IO typically follows:

  • conversion of eligible patients into treated patients
  • persistence and dose intensity trends
  • erosion from competitor IO penetration
  • expansion into new label segments (if approvals land and adoption follows)

For IMFINZI, the main variables are:

  • stability and expansion in Stage III NSCLC consolidation
  • continued penetration in ES-SCLC combination regimens
  • incremental contribution from new approvals in additional tumors

Scenario-based sales projection (high-level, decision-useful)

Because IMFINZI spans multiple indications with heterogeneous adoption curves, a single-point forecast is less useful than a banded scenario view. The projection below is framed as a revenue path in terms of growth and share shifts rather than claiming point certainty on net sales.

Base case (most likely)

  • Modest mid-cycle growth from continued uptake and real-world adherence
  • Plateau risk beginning in the latter half of the decade if competitive peri-treatment strategies strengthen

Upside case

  • Positive label expansions or readouts that widen eligible populations or improve differentiation in lung cancer sequences
  • Slower share erosion due to strong payer contracting and durable clinician preference

Downside case

  • Faster competitive substitution in consolidation or SCLC regimen standards
  • Higher payer restrictions by biomarker, histology, or treatment history that limits penetration

Positioning for investors and R&D teams

What should be treated as “leading indicators” of IMFINZI commercial momentum?

Track the following operational signals because they usually precede reported market share:

  1. Real-world treatment rates

    • Enrollment acceptance in community settings often signals faster-than-expected share capture.
  2. Payer coverage shifts by indication

    • Changes in prior authorization requirements reflect contract renegotiation or competitive pressure.
  3. Regimen switching frequency

    • In SCLC, switches after interim results tend to be faster and more disruptive to forecasting.
  4. Biomarker testing adoption

    • If biomarkers are required, test availability can either accelerate access or bottleneck uptake.

Key Takeaways

  • IMFINZI is anchored in durable IO adoption patterns in lung cancer, especially post-CRT consolidation for unresectable Stage III NSCLC and combination strategies in ES-SCLC.
  • The next value inflection points depend on lung cancer label durability, consolidation uptake, and competitive positioning in SCLC regimen defaults.
  • Forecasting through 2030 should be scenario-based, because practice shifts in IO combinations and payer access rules can change the revenue path quickly.
  • Leading indicators for commercial momentum are treatment rates, payer coverage, regimen switching frequency, and biomarker testing adoption.

FAQs

1) What is IMFINZI’s core commercial engine?

Its core engine is IO consolidation and combination use in lung cancer settings, where durable clinical benefits drive sustained clinician uptake and payer coverage.

2) Which disease area is the biggest driver of future growth risk?

ES-SCLC regimen standards and sequencing are the biggest near-to-mid term risk, because practice can shift rapidly with new IO-chemo combinations.

3) Does IMFINZI’s market outlook depend more on trial outcomes or access policies?

It depends on both, but access policies tend to affect near-term net sales trajectory, while trial outcomes shape the long-term eligibility and differentiation.

4) What type of trial result would most likely expand IMFINZI usage?

Results that widen the treated population through earlier-line positioning or simplified biomarker requirements tend to expand addressable uptake.

5) How should competitors’ progress be monitored for IMFINZI impact?

Monitor competitor trial readouts in peri-CRT consolidation and ES-SCLC combination standards, then track payer and formulary policy changes by indication.


References (APA)

[1] AstraZeneca. (n.d.). IMFINZI (durvalumab) prescribing information and product information. AstraZeneca.

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