NCT00866970 is a Phase 2 clinical trial of ALD518 in NSCLC, sponsored by CSL Behring.

Who is sponsoring NCT00866970?

NCT00866970 is sponsored by CSL Behring.

What drugs are being tested in NCT00866970?

Interventions in NCT00866970: ALD518, ALD518, ALD518, Infusion of 0.9% Saline without ALD518.

What condition does NCT00866970 study?

NCT00866970 studies NSCLC, Fatigue, Cachexia.

Is NCT00866970 still recruiting?

NCT00866970 is currently completed. Last updated 7 July 2020.

Last reviewed 2020-07-07 · How we verify

NCT00866970

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Study to Determine the Safety, Efficacy, and Pharmacokinetics of Multiple Intravenous Doses of ALD518 80 mg, 160 mg, and 320 mg Versus Placebo Administered to Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia

Completed Phase 2 Last updated 7 July 2020

What this trial tests

Phase 2 trial testing ALD518 in NSCLC in 124 participants. Completed in 1 December 2009.

Timeline

1 September 2008

Primary endpoint
1 August 2009

1 December 2009

Quick facts

Lead sponsor	CSL Behring
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	124
Start date	1 September 2008
Primary completion	1 August 2009
Estimated completion	1 December 2009
Sites	43 locations across Australia, Canada, Georgia, India, New Zealand, Poland, Romania, Russia

Drugs / interventions tested

ALD518 — full drug profile →
ALD518 — full drug profile →
ALD518 — full drug profile →
Infusion of 0.9% Saline without ALD518 — full drug profile →

Conditions studied

NSCLC — all drugs for NSCLC →
Fatigue — all drugs for Fatigue →
Cachexia — all drugs for Cachexia →

Sponsor

CSL Behring — full company profile →

Who can join

18 and older, any sex, with NSCLC or Fatigue. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Safety parameters.
Time frame: 20 weeks

Sponsor's own description

The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cachexia: A systemic consequence of progressive, unresolved disease.
Ferrer M, Anthony TG, Ayres JS, Biffi G, et al · · 2023 · cited 180× · PMID 37116469 · DOI 10.1016/j.cell.2023.03.028
Cancer cachexia: molecular mechanisms and treatment strategies.
Setiawan T, Sari IN, Wijaya YT, Julianto NM, et al · · 2023 · cited 176× · PMID 37217930 · DOI 10.1186/s13045-023-01454-0
Molecular Pathways: Cachexia Signaling-A Targeted Approach to Cancer Treatment.
Miyamoto Y, Hanna DL, Zhang W, Baba H, et al · · 2016 · cited 89× · PMID 27340276 · DOI 10.1158/1078-0432.ccr-16-0495
Muscle Wasting Diseases: Novel Targets and Treatments.
Furrer R, Handschin C. · · 2019 · cited 75× · PMID 30148697 · DOI 10.1146/annurev-pharmtox-010818-021041
STAT3: Versatile Functions in Non-Small Cell Lung Cancer.
Mohrherr J, Uras IZ, Moll HP, Casanova E. · · 2020 · cited 74× · PMID 32365499 · DOI 10.3390/cancers12051107
Management of Cancer Cachexia: Attempting to Develop New Pharmacological Agents for New Effective Therapeutic Options.
Marceca GP, Londhe P, Calore F. · · 2020 · cited 63× · PMID 32195193 · DOI 10.3389/fonc.2020.00298
Cancer-associated fibroblasts as therapeutic targets for cancer: advances, challenges, and future prospects.
Cao Z, Quazi S, Arora S, Osellame LD, et al · · 2025 · cited 57× · PMID 39780187 · DOI 10.1186/s12929-024-01099-2
Multicellular Effects of STAT3 in Non-small Cell Lung Cancer: Mechanistic Insights and Therapeutic Opportunities.
Parakh S, Ernst M, Poh AR. · · 2021 · cited 50× · PMID 34944848 · DOI 10.3390/cancers13246228

Verify or expand the search:

Other recruiting trials for NSCLC

Currently open trials in the same condition.

NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
NCT07325864 — Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site · recruiting
NCT07169552 — HC010 in First-line PD-L1 Positive Advanced NSCLC Patients · Phase 2 · recruiting

Other CSL Behring trials

Trials by the same sponsor.

NCT07326592 — Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza · Phase 4 · not yet recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
NCT07332091 — Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary He · Phase 2 · recruiting
NCT07094087 — Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovasc · Phase 3 · recruiting
NCT07048262 — Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NC · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00866970 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CSL Behring
Last refreshed: 7 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00866970.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing